Comparing intensity-modulated radiotherapy with and without chemotherapy for stage II nasopharyngeal carcinoma
Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial
This study is testing whether adding chemotherapy to a type of radiation treatment helps people with stage II nasopharyngeal cancer live longer and have a better quality of life compared to just radiation alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 462 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02610010 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intensity-modulated radiotherapy (IMRT) alone versus IMRT combined with concurrent cisplatin-based chemotherapy in patients with stage II nasopharyngeal carcinoma. Eligible participants will be randomly assigned to one of the two treatment groups, with IMRT administered over 6-7 weeks. The primary goal is to assess overall survival, while secondary outcomes include failure-free survival, locoregional relapse-free survival, distant metastasis-free survival, and quality of life. The study aims to determine if the addition of chemotherapy provides significant benefits in the context of IMRT.
Who should consider this trial
Good fit: Ideal candidates are individuals with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma staged as T1N1M0 or T2N0-1M0.
Not a fit: Patients with prior malignancies, those who are pregnant or lactating, or individuals with a history of previous radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize treatment protocols for patients with stage II nasopharyngeal carcinoma, potentially improving survival rates.
How similar studies have performed: Previous studies have indicated that IMRT is superior to conventional radiotherapy, but the specific combination of IMRT with concurrent chemotherapy for this patient population is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma. * Tumor staged as T1N1M0 or T2N0-1M0 (the 2010 UICC/AJCC staging system). * Karnofsky scale (KPS) ≥ 70. * Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN. * Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN. * Patients must give written informed consent. Exclusion Criteria: * Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume). * Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Fang-Yun Xie, M.D. — Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China
- Study coordinator: Fang-Yun Xie, M.D.
- Email: xiefy@sysucc.org.cn
- Phone: +86-020-87342618
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.