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Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma

RecruitingPhase 3Ages 18 Years - 70 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)โ‰ฅ70. 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 \> 1.5ร—ULN), and mental illness.
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What it tests

  • reduced dosage IMRT
  • conventional dosage IMRT
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Where

6 sites
Sun Yat-sen University Cancer Center
Guangzhou, China
Cancer Center of Guangzhou Medical University
Guangzhou, China
Yuebei People's Hospital
Shaoguan, China
Zhongshan People's Hospital
Zhongshan, China
Wuzhou Red Cross Hospital
Wuzhou, China
National Cancer Centre Singapore
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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