Nasopharyngeal CarcinomaNCT06682442
Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
A study testing Intensity-Modulated Radiation Therapy (IMRT), Radiographic Imaging and Biospecimen Collection in people with Nasopharyngeal Carcinoma and Stage III Nasopharyngeal Carcinoma AJCC v8, run by University of California, San Francisco at 1 site in United States.
Trial summary
This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy [IMRT]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8
- What is being tested?
- Intensity-Modulated Radiation Therapy (IMRT), Radiographic Imaging and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 31 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.
- Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (> 0 copies/mL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.
- Stage III-IVA disease (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:
- History/physical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);
- Evaluation of tumor extent with either one of the following:
- MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or
Show all 21Show fewer
- MRI of the nasopharynx and PET/CT (with contrast) of the neck
- Imaging to rule out distant metastasis:
- CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET/CT scan (non-contrast PET/CT is acceptable); and
- Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
- Started or planning to start platinum-based induction systemic therapy.
- Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.
- Use of adjuvant (post-chemoradiation) immunotherapy is permitted.
- Age >=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.
- For individuals with evidence of chronic hepatitis B virus (HBV) infection: must be on suppressive therapy, if indicated.
- For individuals with a history of hepatitis C virus (HCV) infection: must be currently on treatment, or must have been treated and cured.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 60 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted
- Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
- Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment
- Severe, active comorbidity, defined as any of the following:
- Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential complications of the therapy
- Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude safe administration of study treatment
Show all 13Show fewer
- Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the opinion of the treating investigator
- Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test
- A female participant is considered to NOT be of child-bearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria:
- Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)
- Has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries)
- Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study endpoints
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Imani Dunn, Imani.Dunn@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy [IMRT]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To measure the proportion of participants alive without progression of disease two years following induction therapy (IT) response-guided IMRT.
SECONDARY OBJECTIVES:
- To assess the 1-year rate of progression-free survival (PFS) after IT response-guided IMRT.
II. To assess the 1- and 2-year cumulative incidence of locoregional recurrence (LRR) after IT response-guided IMRT.
III. To assess the 1- and 2-year cumulative incidence of distant metastasis (DM) after IT response-guided IMRT.
IV. To assess the 1- and 2-year rates of overall survival (OS) after IT response-guided IMRT.
- To compare the rates of severe acute toxicities between standard and de-escalated IMRT.
VI. To compare the rates of severe late toxicities between standard and response-guided IMRT over a period of 2 years.
EXPLORATORY OBJECTIVES:
- To compare the frequency of radiation treatment breaks between standard and de-escalated IMRT.
II. To compare the frequency of hospitalizations between standard and de-escalated IMRT.
III. To compare pre-treatment and short- and long-term post-treatment quality of life (QoL) after standard versus de-escalated IMRT.
IV. To compare pre-treatment and short- and long-term post-treatment levels of fatigue after standard versus de-escalated IMRT.
- To compare radiation dosimetric parameters between standard and de-escalated IMRT.
VI. To explore differences in efficacy endpoints by sex, age, English language status, and race/ethnicity.
VII. To explore heterogeneity of treatment effects (HTEs) of efficacy endpoints by variables, such as sex, age, English language status, and race/ethnicity.
VIII. To explore the association between EBV deoxyribonucleic acid (DNA) levels and disease response on imaging upon completion of IT.
IX. To explore longitudinal EBV DNA levels after completion of IT response-guided IMRT.
- To compare the rates of severe very late toxicities (from years 2 to 10 after completion of IMRT) between standard and response-guided IMRT.
XI. To explore the association between adjuvant (post-chemoradiation) systemic therapy use and oncologic outcomes (PFS, locoregional recurrence, distant metastasis, and overall survival), quality of life, and fatigue.
XII. To assess frequency of intra-treatment tumor hypoxia in participants undergoing standard and de-escalated radiotherapy.
XII. To explore the association between the presence of intra-treatment tumor hypoxia and baseline demographic and clinical characteristics.
XIV. To explore the association between the presence of intra-treatment tumor hypoxia and oncologic outcomes, toxicity, quality of life, and fatigue.
XV. To evaluate the relationship between intra-treatment tumor hypoxia and pre-treatment EBV DNA levels.
XVI. To evaluate the relationship between intra-treatment tumor hypoxia and end-of-treatment EBV DNA levels.
OUTLINE: Patients with partial radiographic response to IT in the primary tumor and lymph nodes are assigned to Arm I. Patients with stable or progressive disease are assigned to Arm II.
ARM I (DE-ESCALATED INTENSITY): Patients undergo de-escalated IMRT once daily (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)/magnetic resonance imaging (MRI), positron emission tomography (PET), PET/CT, CT, and/or bone scans throughout the trial
ARM II (STANDARD): Patients undergo standard IMRT QD on 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI, PET, PET/CT, CT, and/or bone scans throughout the trial.
After completion of study treatment, patients are followed up at 3 months then every 6 months for up to 10 years.
- Conditions
- Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Nasopharyngeal Cancer, Nasopharyngeal Cancer Stage
- Being tested
- Intensity-Modulated Radiation Therapy (IMRT), Radiographic Imaging, Biospecimen Collection
- Keywords
- HHV-4 Positive, EBV Positive, human herpesvirus 4 (HHV-4) positive
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiation Therapy (IMRT)Radiation
Also called IMRT, Intensity Modulated RT
Undergo IMRT
Radiographic ImagingProcedure or surgery
Also called PET Scan, Positron Emission Tomography (PET), Computed Tomography (CT), CT
Undergo imaging procedure
Biospecimen CollectionProcedure or surgery
Also called Blood Specimen, Blood Sample
Blood samples will be collected
| Study group | Role | What they receive |
|---|---|---|
| Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT) | Experimental | Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial. Receives: Radiation: Intensity-Modulated Radiation Therapy (IMRT); Procedure: Radiographic Imaging; Procedure: Biospecimen Collection |
| Arm II (standard IMRT) | Experimental | Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial. Receives: Radiation: Intensity-Modulated Radiation Therapy (IMRT); Procedure: Radiographic Imaging; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Rate (PFS) at 2 years post radiation
PFS is defined as the proportion of participants alive without progression of disease from the first day of radiotherapy to progression or death by any cause, whichever occurs first, assessed up to 2 years after the last day of radiation therapy. The Kaplan-Meier method will be used to estimate the PFS rate along with a 90% confidence interval.
Measured: Up to 26 months
Secondary outcomes (10)
Progression-Free Survival Rate (PFS) at 1 year post radiation
PFS is defined as the proportion of participants alive without progression of disease from the first day of radiotherapy to progression or death by any cause, whichever occurs first, assessed up to 1 year after the last day of radiation therapy. The Kaplan-Meier method will be used to estimate the PFS rate along with a 90% confidence interval.
Measured: Up to 14 months
Locoregional recurrence rate (LRR) at 1 year post radiation
LRR will be estimated using cumulative incidence from the first day of radiation to 1 year after the last day of radiation.
Measured: Up to 14 months
Locoregional recurrence rate (LRR) at 2 years post radiation
LRR will be estimated using cumulative incidence from the first day of radiation to 2 years after the last day of radiation.
Measured: Up to 26 months
Incidence of Distant metastasis (DM) at 1 year post radiation
DM will be estimated using cumulative incidence from the first day of radiation to 1 year after the last day of radiation.
Measured: Up to 14 months
Incidence of Distant metastasis (DM) at 2 years post radiation
DM will be estimated using cumulative incidence from the first day of radiation to 2 years after the last day of radiation.
Measured: Up to 26 months
Median Overall Survival (OS) at 1 year post radiation
Kaplan-Meier will be used to estimate OS
Measured: Up to 14 months
Median Overall Survival (OS) at 2 years post radiation
Kaplan-Meier will be used to estimate OS
Measured: Up to 26 months
Overall Proportion of patients with grade ≥ 3 adverse events (AEs)
Adverse Events will be reported from the start of radiation until 3 months after completion of radiation and will be graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The percent of participants will be reported overall.
Measured: Up to 5 months
Proportion of patients with acute grade ≥ 3 adverse events (AEs) by group
Any adverse events from the start of radiation until 3 months after completion of radiation with a grade 3 or higher as determined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 will be reported as a percentage of the total participants for each treatment group.
Measured: Up to 5 months
Proportion of patients with late onset grade ≥ 3 AEs by group post radiation
Any adverse events from 3 months after completion radiation until 2 years after completion of radiation, with a grade 3 or higher as determined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 will be reported as a percentage of the total participants for each treatment group.
Measured: Up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start18 Mar 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sue Yom, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682442
- Sponsor's protocol ID
- 24726
- Other IDs
- NCI-2024-08983
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06682442
- Acronym / sponsor ID
- 24726
- Conditions
- Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Nasopharyngeal Cancer, Nasopharyngeal Cancer Stage
- Keywords
- HHV-4 Positive, EBV Positive, human herpesvirus 4 (HHV-4) positive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy [IMRT]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.
Detailed description
PRIMARY OBJECTIVE:
- To measure the proportion of participants alive without progression of disease two years following induction therapy (IT) response-guided IMRT.
SECONDARY OBJECTIVES:
- To assess the 1-year rate of progression-free survival (PFS) after IT response-guided IMRT.
II. To assess the 1- and 2-year cumulative incidence of locoregional recurrence (LRR) after IT response-guided IMRT.
III. To assess the 1- and 2-year cumulative incidence of distant metastasis (DM) after IT response-guided IMRT.
IV. To assess the 1- and 2-year rates of overall survival (OS) after IT response-guided IMRT.
- To compare the rates of severe acute toxicities between standard and de-escalated IMRT.
VI. To compare the rates of severe late toxicities between standard and response-guided IMRT over a period of 2 years.
EXPLORATORY OBJECTIVES:
- To compare the frequency of radiation treatment breaks between standard and de-escalated IMRT.
II. To compare the frequency of hospitalizations between standard and de-escalated IMRT.
III. To compare pre-treatment and short- and long-term post-treatment quality of life (QoL) after standard versus de-escalated IMRT.
IV. To compare pre-treatment and short- and long-term post-treatment levels of fatigue after standard versus de-escalated IMRT.
- To compare radiation dosimetric parameters between standard and de-escalated IMRT.
VI. To explore differences in efficacy endpoints by sex, age, English language status, and race/ethnicity.
VII. To explore heterogeneity of treatment effects (HTEs) of efficacy endpoints by variables, such as sex, age, English language status, and race/ethnicity.
VIII. To explore the association between EBV deoxyribonucleic acid (DNA) levels and disease response on imaging upon completion of IT.
IX. To explore longitudinal EBV DNA levels after completion of IT response-guided IMRT.
- To compare the rates of severe very late toxicities (from years 2 to 10 after completion of IMRT) between standard and response-guided IMRT.
XI. To explore the association between adjuvant (post-chemoradiation) systemic therapy use and oncologic outcomes (PFS, locoregional recurrence, distant metastasis, and overall survival), quality of life, and fatigue.
XII. To assess frequency of intra-treatment tumor hypoxia in participants undergoing standard and de-escalated radiotherapy.
XII. To explore the association between the presence of intra-treatment tumor hypoxia and baseline demographic and clinical characteristics.
XIV. To explore the association between the presence of intra-treatment tumor hypoxia and oncologic outcomes, toxicity, quality of life, and fatigue.
XV. To evaluate the relationship between intra-treatment tumor hypoxia and pre-treatment EBV DNA levels.
XVI. To evaluate the relationship between intra-treatment tumor hypoxia and end-of-treatment EBV DNA levels.
OUTLINE: Patients with partial radiographic response to IT in the primary tumor and lymph nodes are assigned to Arm I. Patients with stable or progressive disease are assigned to Arm II.
ARM I (DE-ESCALATED INTENSITY): Patients undergo de-escalated IMRT once daily (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)/magnetic resonance imaging (MRI), positron emission tomography (PET), PET/CT, CT, and/or bone scans throughout the trial
ARM II (STANDARD): Patients undergo standard IMRT QD on 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI, PET, PET/CT, CT, and/or bone scans throughout the trial.
After completion of study treatment, patients are followed up at 3 months then every 6 months for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT) | Experimental | Radiation: Intensity-Modulated Radiation Therapy (IMRT), Procedure: Radiographic Imaging, Procedure: Biospecimen CollectionParticipants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial. |
| Arm II (standard IMRT) | Experimental | Radiation: Intensity-Modulated Radiation Therapy (IMRT), Procedure: Radiographic Imaging, Procedure: Biospecimen CollectionPatients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must have histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.
- Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (> 0 copies/mL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.
- Stage III-IVA disease (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:
- Started or planning to start platinum-based induction systemic therapy.
- Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.
Key exclusion criteria (13 listed)
- Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted
- Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
- Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment
- Severe, active comorbidity, defined as any of the following:
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Modulated Radiation Therapy (IMRT)Also: IMRT, Intensity Modulated RTUndergo IMRT | Radiation | Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT), Arm II (standard IMRT) |
| Radiographic ImagingAlso: PET Scan, Positron Emission Tomography (PET), Computed Tomography (CT), CTUndergo imaging procedure | Procedure or surgery | Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT), Arm II (standard IMRT) |
| Biospecimen CollectionAlso: Blood Specimen, Blood SampleBlood samples will be collected | Procedure or surgery | Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT), Arm II (standard IMRT) |
Primary outcome
Progression-Free Survival Rate (PFS) at 2 years post radiation
Time frame: Up to 26 months
PFS is defined as the proportion of participants alive without progression of disease from the first day of radiotherapy to progression or death by any cause, whichever occurs first, assessed up to 2 years after the last day of radiation therapy. The Kaplan-Meier method will be used to estimate the PFS rate along with a 90% confidence interval.
10 secondary outcomes
Progression-Free Survival Rate (PFS) at 1 year post radiation
Time frame: Up to 14 months
Locoregional recurrence rate (LRR) at 1 year post radiation
Time frame: Up to 14 months
Locoregional recurrence rate (LRR) at 2 years post radiation
Time frame: Up to 26 months
Incidence of Distant metastasis (DM) at 1 year post radiation
Time frame: Up to 14 months
Incidence of Distant metastasis (DM) at 2 years post radiation
Time frame: Up to 26 months
Median Overall Survival (OS) at 1 year post radiation
Time frame: Up to 14 months
Median Overall Survival (OS) at 2 years post radiation
Time frame: Up to 26 months
Overall Proportion of patients with grade ≥ 3 adverse events (AEs)
Time frame: Up to 5 months
Proportion of patients with acute grade ≥ 3 adverse events (AEs) by group
Time frame: Up to 5 months
Proportion of patients with late onset grade ≥ 3 AEs by group post radiation
Time frame: Up to 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Yom, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity-Modulated Radiation Therapy (IMRT), Radiographic Imaging and Biospecimen Collection in people with Nasopharyngeal Carcinoma and Stage III Nasopharyngeal Carcinoma AJCC v8, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imani Dunn (877-827-3222, Imani.Dunn@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival Rate (PFS) at 2 years post radiation (time frame: Up to 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.