Head and Neck Squamous Cell CarcinomaNCT05854823
The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR
A study testing dose-reduced radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- dose-reduced radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2023to 9 Apr 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; within 6 weeks after receiving neoadjuvant therapy and radical surgery.
- Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response, residual viable tumor cells≤10%).
- Negative surgical margin.
- No extranodal extension.
- Aged ≥ 18 years and ≤ 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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- Life expectancy of more than 6 months.
- Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
- Hemoglobin ≥ 75 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; and platelet count ≥ 100 × 10^9/L;
- Serum albumin ≥ 25 g/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN;
- Serum creatinine ≤ 1.5 × ULN;
- Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).
- Women of childbearing age should agree to the use of contraception (e.g., intrauterine devices, birth control pills, or condoms) during treatment and for 3 months thereafter.
- The regimen of neoadjuvant therapy can be determined by the clinician.
- Subjects voluntarily join the study and sign an informed consent form, with good compliance.
Who cannot join
- Pregnant or lactating women.
- A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
- Neoadjuvant therapy or radical surgery was not completed.
- Recurrence or distant metastasis occurred before postoperative radiotherapy.
- There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
- Uncontrolled cardiac clinical symptoms or diseases.
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- Serious infections.
- A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
- Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
- Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).
- Known history of psychotropic drug abuse, alcoholism and drug use.
- Not suitable for inclusion, as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Yingpeng Peng, Dr., 07562526191, pengyp3@outlook.com
About this study
Official title: De-escalation of Postoperative Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma With Pathological Complete Response/Major Pathological Response: A Single-arm, Prospective Phase II Clinical Study
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- dose-reduced radiotherapy
- Keywords
- pathological complete response, major pathological response
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose-reduced radiotherapyRadiation
Patients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| de-escalation radiotherapy | Experimental | Postoperative radiotherapy alone Receives: Radiation: dose-reduced radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
2-year disease free survival rate
Measured: from the first day of treatment to the follow up of 2 years
Secondary outcomes (6)
Overall Survival (OS)
2-year overall survival rate
Measured: from the first day of treatment to the follow up of 2 years
Local Relapse Free Survival (LRFS)
2-year local relapse free survival rate
Measured: from the first day of treatment to the follow up of 2 years
Distant Metastasis Free Survival (DMFS)
2-year distant metastasis free survival rate
Measured: from the first day of treatment to the follow up of 2 years
EORTC QLQ-C30
Quality of life evaluation
Measured: from 1 week before treatment to the follow up of 2 years
EORTC HN35
Quality of life evaluation
Measured: from 1 week before treatment to the follow up of 2 years
RTOG/EORTC late radiation morbidity scoring scheme
Toxicity criteria of RTOG/EORTC
Measured: from 1 week before treatment to the follow up of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 Apr 2023
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpeng Peng, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854823
- Sponsor's protocol ID
- ZDWY.TJBZLK.002
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Postoperative Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma With Pathological Complete Response/Major Pathological Response: A Single-arm, Prospective Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05854823
- Acronym / sponsor ID
- ZDWY.TJBZLK.002
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- pathological complete response, major pathological response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 11 May 2023 (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 is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| de-escalation radiotherapy | Experimental | Radiation: dose-reduced radiotherapyPostoperative radiotherapy alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; within 6 weeks after receiving neoadjuvant therapy and radical surgery.
- Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response, residual viable tumor cells≤10%).
- Negative surgical margin.
- No extranodal extension.
- Aged ≥ 18 years and ≤ 70 years.
Key exclusion criteria (12 listed)
- Pregnant or lactating women.
- A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
- Neoadjuvant therapy or radical surgery was not completed.
- Recurrence or distant metastasis occurred before postoperative radiotherapy.
- There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
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 |
|---|---|---|
| dose-reduced radiotherapyPatients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks | Radiation | de-escalation radiotherapy |
Primary outcome
Disease Free Survival (DFS)
Time frame: from the first day of treatment to the follow up of 2 years
2-year disease free survival rate
6 secondary outcomes
Overall Survival (OS)
Time frame: from the first day of treatment to the follow up of 2 years
Local Relapse Free Survival (LRFS)
Time frame: from the first day of treatment to the follow up of 2 years
Distant Metastasis Free Survival (DMFS)
Time frame: from the first day of treatment to the follow up of 2 years
EORTC QLQ-C30
Time frame: from 1 week before treatment to the follow up of 2 years
EORTC HN35
Time frame: from 1 week before treatment to the follow up of 2 years
RTOG/EORTC late radiation morbidity scoring scheme
Time frame: from 1 week before treatment to the follow up of 2 years
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 11 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dose-reduced radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 16 inclusion and 12 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 11 May 2023. 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 China. 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 Yingpeng Peng, Dr. (07562526191, pengyp3@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: from the first day of treatment to the follow up of 2 years). 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 11 May 2023.