Nasopharyngeal CarcinomaPhase 3NCT04448522
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
A Phase 3 study testing reduced dosage IMRT and conventional dosage IMRT in people with Nasopharyngeal Carcinoma and Radiotherapy, run by Sun Yat-sen University at 6 sites in 2 countries.
Trial summary
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Radiotherapy, Chemotherapy
- What is being tested?
- reduced dosage IMRT and conventional dosage IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Aug 2020to Aug 2028
- Phase
- Phase 3
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
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
- Aged between 18-70 years.
- Karnofsky scale (KPS)≥70.
- Normal bone marrow function.
- Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
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- EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
- Normal liver and kidney function:
- total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- Given written informed consent.
Who cannot join
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
- Recurrent or metastatic nasopharyngeal carcinoma.
- Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
- EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
- Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
- Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
- Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
- Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and mental illness.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
China5 sites, 5 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD, PhD, 86-20-8734-3361, chmingy@mail.sysu.edu.cn
Rui You, MD, PhD, 86-13580439820, yourui@sysucc.org.cn
- Not yet recruiting
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Dong-Ping Chen, MD, 86-13302215492, chen_dpgz@163.com
Bin Qi, PhD, qibin020@126.com
- Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guangdong, 512025
Su-Ming Pan, MD, 86-13826331948
Xiang-Guo Zhang, MD, 86-13826380511, 1178906911@qq.com
- Not yet recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Jin-Hui Liang, MD, 86-13878480806
Jin-Hui Liang, MD
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Feng Lei, MD, 86-18933345382
Feng Lei, MD
Singapore1 site, 1 recruiting
- Not yet recruiting
National Cancer Centre Singapore
Singapore, 169610
Melvin Lee Kiang Chua, PhD, 65-6436-8000, melvin.chua.l.k@singhealth.com.sg
Melvin Lee Kiang Chua, PhD
About this study
Official title: A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
Read the detailed description
Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.
- Conditions
- Nasopharyngeal Carcinoma, Radiotherapy, Chemotherapy
- Being tested
- reduced dosage IMRT, conventional dosage IMRT
- Keywords
- Nasopharyngeal carcinoma, intensity-modulated radiotherapy, chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced dosage IMRTRadiation
- Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
- Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
- IMRT: PTVnx：63.6Gy/30Fr/2.12Gy; PTVnd：63.6Gy/30Fr/2.12Gy; PTV1：54Gy/30Fr/1.8Gy; PTV2：49.2Gy/30Fr/1.64Gy
conventional dosage IMRTRadiation
- Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
- Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
- IMRT: PTVnx：69.96Gy/33Fr/2.12Gy; PTVnd：69.96Gy/33Fr/2.12Gy; PTV1：59.4Gy/33Fr/1.8Gy; PTV2：54Gy/33Fr/1.64Gy
| Study group | Role | What they receive |
|---|---|---|
| Reduced dosage IMRT group | Experimental | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy Receives: Radiation: reduced dosage IMRT |
| Conventional dosage IMRT group | Active comparator | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy Receives: Radiation: conventional dosage IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (7)
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Measured: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 3 years
Incidence of treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: up to 1 years
Incidence of treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: up to 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Measured: up to 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start18 Aug 2020
- Primary completionAug 2026 (estimated)
- Study completionAug 2028 (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 Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Yuebei People's Hospital, Wuzhou Red Cross Hospital
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448522
- Sponsor's protocol ID
- SYSUCC-MYC-2020-1201
- Status last verified
- Sep 2020
- First submitted
- 24 Jun 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No