Comparing reduced and conventional radiotherapy doses for nasopharyngeal carcinoma
A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
This study is testing whether a lower dose of radiotherapy is just as effective and safe as the standard dose for patients with stage II-III nasopharyngeal cancer who have already received chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Guangzhou, Guangdong and 5 other locations) |
| Trial ID | NCT04448522 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of reduced dosage intensity-modulated radiotherapy (IMRT) compared to conventional dosage IMRT in patients with stage II-III nasopharyngeal carcinoma who are sensitive to induction chemotherapy. Patients will be randomized into two groups: one receiving reduced dose IMRT and the other receiving conventional dose IMRT, with both groups also undergoing two cycles of cisplatin chemotherapy. The study will assess the incidence of radiotherapy-related toxicities, quality of life, and tumor control rates. The trial is multicenter and open-label, ensuring a diverse patient population and robust data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed non-keratinizing nasopharyngeal carcinoma staged as II-III and who have responded positively to induction chemotherapy.
Not a fit: Patients with keratinized squamous cell carcinoma, recurrent or metastatic nasopharyngeal carcinoma, or those not responding to induction chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective treatment option for patients with nasopharyngeal carcinoma, reducing side effects while maintaining tumor control.
How similar studies have performed: Other studies have shown promising results with reduced dosage radiotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). 2. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition). 3. Aged between 18-70 years. 4. Karnofsky scale (KPS)≥70. 5. Normal bone marrow function. 6. Evaluated as PR or CR after 3 cycles of GP induction chemotherapy. 7. EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy. 8. Normal liver and kidney function: 1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit; 2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit. 9. Given written informed consent. Exclusion Criteria: 1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma. 2. Recurrent or metastatic nasopharyngeal carcinoma. 3. Evaluated as SD or PD after 3 cycles of GP induction chemotherapy. 4. EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy. 5. Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.) 6. Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ. 7. Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose) 8. 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.
Where this trial is running
Guangzhou, Guangdong and 5 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Cancer Center of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Yuebei People's Hospital — Shaoguan, Guangdong, China (Not_yet_recruiting)
- Zhongshan People's Hospital — Zhongshan, Guangdong, China (Recruiting)
- Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Not_yet_recruiting)
- National Cancer Centre Singapore — Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Study coordinator: Ming-Yuan Chen, MD, PhD
- Email: chmingy@mail.sysu.edu.cn
- Phone: 86-20-87343624
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.