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 (8) 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 (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: 0;

⁃ 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
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Cancer Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Hubei Province Cancer Hosiptal
NOT_YET_RECRUITING
Wuhan
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Zhongshan city Peaple's Hospital
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
Jun Ma
majun2@mail.sysu.edu.cn
+862087343469
Backup
Kaibin 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-enrolled 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