Locally Recurrent Nasopharyngeal CarcinomaPhase 2NCT04533620
Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Standardized CIRT and Individualized CIRT in people with Locally Recurrent Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- Standardized CIRT and Individualized CIRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Aged between 17-70 years.
- Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma.
- Failed previous definitive radiotherapy at least 6 months ago.
- Only had 1 previous course of radiotherapy.
- Eastern Cooperative Oncology Group score: 0-1.
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
- Willing to accept adequate contraception for women with childbearing potential.
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
Who cannot join
- Presence of distant metastasis.
- Without measurable lesion.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Accompanied with severe major organ dysfunction.
- Presence of mental disease that may influence the understanding of informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
Lin Kong, MD, lin.kong@sphic.org.cn
Jiyi Hu, MD, jiyi.hu@sphic.org.cn
About this study
Official title: Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
Read the detailed description
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized CIRT with a dose of 63 gray equivalent (GyE) in 21 fractions (fx). This regimen was obtained from our previous phase 1 (dose escalation) study. For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups. The secondary endpoints include 2-year overall survival (OS), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.
- Being tested
- Standardized CIRT, Individualized CIRT
- Keywords
- Locally recurrent nasopharyngeal carcinoma, Individualized carbon-ion radiotherapy, Predictive model of mucosal necrosis, Survival, Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized CIRTRadiation
CIRT with a dose of 63 GyE/21 fx
Individualized CIRTRadiation
A predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Standardized CIRT | Active comparator | Patients will receive standardized CIRT with a dose of 63 GyE/21 fx. Receives: Radiation: Standardized CIRT |
| Individualized CIRT | Experimental | A previously predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. Receives: Radiation: Individualized CIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: From randomization to death or disease progression, a median of 2 years
Secondary outcomes (8)
Overall survival
Measured: From randomization to death, a median of 2 years
Local progression-free survival
Measured: From randomization to local failure, a median of 2 years
Regional progression-free survival
Measured: From randomization to regional failure, a median of 2 years
Distant metastasis-free survival
Measured: From randomization to distant metastasis, a median of 2 years
Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0
Measured: Within 3 months after initiation of radiation therapy
Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0
Measured: Three months after initiation of radiation therapy
Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.
Measured: Throughout the study, an average of 2 years
Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.
Measured: Throughout the study, an average 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 posted31 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Nasopharyngeal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533620
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2020-46
- Status last verified
- Oct 2020
- First submitted
- 24 Aug 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
- ClinicalTrials.gov ID
- NCT04533620
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2020-46
- Keywords
- Locally recurrent nasopharyngeal carcinoma, Individualized carbon-ion radiotherapy, Predictive model of mucosal necrosis, Survival, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 31 Aug 2020 (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 a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
Detailed description
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized CIRT with a dose of 63 gray equivalent (GyE) in 21 fractions (fx). This regimen was obtained from our previous phase 1 (dose escalation) study. For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups. The secondary endpoints include 2-year overall survival (OS), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized CIRT | Active comparator | Radiation: Standardized CIRTPatients will receive standardized CIRT with a dose of 63 GyE/21 fx. |
| Individualized CIRT | Experimental | Radiation: Individualized CIRTA previously predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 17-70 years.
- Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma.
- Failed previous definitive radiotherapy at least 6 months ago.
- Only had 1 previous course of radiotherapy.
- Eastern Cooperative Oncology Group score: 0-1.
Key exclusion criteria (5 listed)
- Presence of distant metastasis.
- Without measurable lesion.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Accompanied with severe major organ dysfunction.
- Presence of mental disease that may influence the understanding of informed consent.
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 |
|---|---|---|
| Standardized CIRTCIRT with a dose of 63 GyE/21 fx | Radiation | Standardized CIRT |
| Individualized CIRTA predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. | Radiation | Individualized CIRT |
Primary outcome
Progression-free survival
Time frame: From randomization to death or disease progression, a median of 2 years
8 secondary outcomes
Overall survival
Time frame: From randomization to death, a median of 2 years
Local progression-free survival
Time frame: From randomization to local failure, a median of 2 years
Regional progression-free survival
Time frame: From randomization to regional failure, a median of 2 years
Distant metastasis-free survival
Time frame: From randomization to distant metastasis, a median of 2 years
Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0
Time frame: Within 3 months after initiation of radiation therapy
Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0
Time frame: Three months after initiation of radiation therapy
Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.
Time frame: Throughout the study, an average of 2 years
Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.
Time frame: Throughout the study, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: Yes. Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
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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. This study is not recruiting at the moment.
Jiade J Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized CIRT and Individualized CIRT in people with Locally Recurrent Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Kong, MD (+8602138296666-53516, lin.kong@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From randomization to death or disease progression, a median 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 20 Oct 2020.