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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 18 Years to 65 Years;

• Eastern Cooperative Oncology Group performance status ≤1;

• Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;

• Tumor staged as Stage III (T3N0 Excepted; AJCC 8th);

• Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion);

• Normal bone marrow function: white blood cell count \> 4×10\^9/L, hemoglobin \> 90g/L, platelet count \> 100×10\^9/L;

• Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate transaminase ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, creatinine clearance rate ≥ 60 ml/min;

• Receive 3 cycles of indction chemotherapy (GP regimen + Camrelizumab);

• Plasma EBV DNA after the second cycle of concurrent chemotherapy: negative;

⁃ Complete remission after 27 fractions of radiotherapy based on the MRI examination of the nasopharynx and neck (According to Response Evaluation Criteria in Solid Tumors 1.1);

⁃ Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;

⁃ Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
West China Hospital,Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Dongguan People's Hospital
RECRUITING
Dongguan
The First People's Hospital of Foshan
RECRUITING
Foshan
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
The Affiliated Panyu Central Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Cancer Hospital of Guizhou Medical University
RECRUITING
Guiyang
The Second Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Jiangxi Cancer Center
RECRUITING
Nanchang
Jiangsu Cancer Hospital
RECRUITING
Nanjing
Jiangsu Provinee Hospital of Chinese Medicine
RECRUITING
Nanjing
Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Hubei Province Cancer Hosiptal
RECRUITING
Wuhan
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xian
Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
Guangdong Nongken Central Hospital
RECRUITING
Zhanjiang
Contact Information
Primary
Jun Ma
majun2@mail.sysu.edu.cn
+862087343469
Backup
Kai-Bin Yang
yangkb@sysucc.org.cn
+8613725368062
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2030-02-20
Participants
Target number of participants: 593
Treatments
Experimental: Reduced-dose radiotherapy group
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by reduced-dose intensity-modulated radiation therapy (IMRT; 6360cGy, 30 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.
Active_comparator: Conventional-dose radiotherapy group
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.
Other: Not-Randomized population
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. Besides, all the participants should also receive metronomic adjuvant capecitabine chemotherapy (capecitabine 650 mg/m2 p.o. BID 1 year) immediately after the completion of concurrent chemoradiotherapy.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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