RecruitingPhase 3NCT04448522

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

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

Sponsor

Sun Yat-sen University

Enrollment

508 participants

Start Date

Aug 18, 2020

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Radiotherapy Nasopharyngeal Carcinoma

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)

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a reduced dose of radiation therapy is as effective as the standard dose for people with locally advanced nasopharyngeal carcinoma (a type of head and neck cancer) who respond well to chemotherapy given before radiation. **You may be eligible if...** - You have a confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (WHO type II or III) - Your cancer is stage II or III - You responded well (partial or complete response) to induction chemotherapy - You have not had prior radiation to the head or neck **You may NOT be eligible if...** - You have the keratinizing type (WHO type I) of nasopharyngeal cancer - Your cancer has spread to distant organs (metastatic) - Your cancer did not respond to initial chemotherapy - You have significant hearing or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONreduced 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

RADIATIONconventional 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