This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
This study intends to enroll low-risk intermediate-stage nasopharyngeal carcinoma patients who achieve CR/PR after induction chemotherapy and whose plasma EBV-DNA level has dropped to 0 or below the lower detection limit. These patients will be randomly assigned at a 1:1 ratio to receive either reduced-dose radiotherapy (40.2Gy) or conventional-dose radiotherapy (49.2Gy) to CTV2. Both groups will receive full-course immunotherapy. The study will follow up to observe differences in survival, adverse events, and quality of life between the two groups. It is expected that, on the premise of maintaining treatment efficacy, reducing the dose to CTV2 can decrease acute and chronic toxicities caused by radiotherapy and chemotherapy, thereby improving patients' quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
346
Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)
Tislelizumab 200 mg , once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
Progress-Free Survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time frame: 3 years
Incidence of ≥3 grade adverse events
According to NCI-CTCAE 5.0, the proportion of patients who experienced ≥3 grade adverse events during treatment and follow-up.
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomization to the date of first distant metastases.
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Time frame: 3 years
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Time frame: 3 years
Objective Response Rate (ORR)
Defined as the proportion of patients with tumor reduction achieving complete response (CR) or partial response (PR), assessed at 3 months after the end of concurrent chemoradiotherapy.
Time frame: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 3 years
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GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy
GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
RECRUITINGthe Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGCancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGZhongshan City People's Hospital
Zhongshan, Guangdong, China
RECRUITINGThe Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGWuzhou Red Cross Hospital
Wuzhou, Guangxi, China
RECRUITINGCentral South University Cancer Hospital,
Changsha, Hunan, China
RECRUITING...and 5 more locations
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: 3 years