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RECRUITING
NCT04448522
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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 sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)

Official title: A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

508

Start Date

2020-08-18

Completion Date

2028-08

Last Updated

2020-09-28

Healthy Volunteers

No

Interventions

RADIATION

reduced dosage IMRT

1. 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. 2. 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. 3. IMRT: PTVnx:63.6Gy/30Fr/2.12Gy; PTVnd:63.6Gy/30Fr/2.12Gy; PTV1:54Gy/30Fr/1.8Gy; PTV2:49.2Gy/30Fr/1.64Gy

RADIATION

conventional dosage IMRT

1. 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. 2. 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. 3. IMRT: PTVnx:69.96Gy/33Fr/2.12Gy; PTVnd:69.96Gy/33Fr/2.12Gy; PTV1:59.4Gy/33Fr/1.8Gy; PTV2:54Gy/33Fr/1.64Gy

Locations (6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

National Cancer Centre Singapore

Singapore, Singapore