RecruitingPhase 3NCT06239727

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response: an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial

Sponsor

Sun Yat-sen University

Enrollment

593 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

Summary

This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with stage III nasopharyngeal carcinoma (a cancer at the back of the nasal cavity) who respond very well to initial treatment can safely receive a lower total radiation dose, potentially reducing long-term side effects of radiotherapy without compromising cancer control. **You may be eligible if...** - You are between 18 and 65 years old - You have newly diagnosed, histologically confirmed stage III nasopharyngeal carcinoma (non-keratinising type) - You completed 3 cycles of induction chemotherapy (a specific GP regimen plus camrelizumab) - After part of your radiotherapy, your EBV DNA test was negative and your MRI showed complete tumor remission - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have active hepatitis B - Your lymph nodes show features such as central necrosis, skin or muscle invasion, or fused nodes - You did not achieve complete remission after the initial phase of treatment - You are pregnant or not willing to use contraception 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

DRUGPD-1 blocking antibody

1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC. 2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

DRUGGemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

DRUGCisplatin (80 mg/m2)

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

RADIATIONReduced-dose Intensity-modulated radiotherapy

1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

RADIATIONConventional-dose Intensity-modulated radiotherapy

1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

DRUGCisplatin (100 mg/m2)

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

DRUGCapecitabine

Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Locations(26)

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

The Affiliated Panyu Central Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Guangdong Nongken Central Hospital

Zhanjiang, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Hubei Province Cancer Hosiptal

Wuhan, Hubei, China

Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Provinee Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Jiangxi Cancer Center

Nanchang, Jiangxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xian, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Chongqing Cancer Hospital

Chongqing, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT06239727

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