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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy | Experimental |
| |
| Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin-based induction chemotherapy | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-Free Survival (PFS) | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS) | Defined as the time interval from randomization to the date of first distant metastases. | 3 years |
| Locoregional Relapse-Free Survival (LRRFS) | Defined as the time from randomisation to the date of first locoregional relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD,PhD | Contact | +86-20-87343361 | chenmy@sysucc.org.cn | |
| Rui You, MD,PhD | Contact | +86-13580439820 | your5@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | China |
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| Full course of PD-1 monoclonal antibody | Drug | 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. |
|
| Reduced-dose radiotherapy to CTV2 | Radiation | GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy |
|
| Conventional-dose radiotherapy to CTV2 | Radiation | GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy |
|
| 3 years |
| Overall Survival (OS) | Defined as the time interval from randomization to death due to any cause. | 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. | 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. | 3 years |
| 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. | 3 years |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
|
| Sun Yat-sen University cancer center | Recruiting | Guangzhou | Guangdong | China |
|
| the Affiliated Cancer Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| Cancer Hospital of Shantou University Medical College | Recruiting | Shantou | Guangdong | China |
|
| Zhongshan City People's Hospital | Recruiting | Zhongshan | Guangdong | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | China |
|
| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | China |
|
| Wuzhou Red Cross Hospital | Recruiting | Wuzhou | Guangxi | China |
|
| Central South University Cancer Hospital, | Recruiting | Changsha | Hunan | China |
|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
|
| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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