Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy plus conventional concurrent chemoradiotherapy | Active Comparator |
| |
| Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy | Experimental |
| |
| Induction chemotherapy plus reduced-dose radiotherapy alone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin-based induction chemotherapy | Drug | Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time interval from randomization to death due to any cause. | 3 years |
| Locoregional Relapse-Free Survival (LRRFS) | Defined as the time from randomisation to the date of first locoregional relapse. |
Not provided
Inclusion Criteria:
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Tumor staged as III-IVA (AJCC 8th, except T3N0).
Patients who achieved both radiological and biological CR according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy, and EBV DNA load =0 copies/mL (or lower than the test line) after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
Eastern Cooperative Oncology Group performance status ≤1.
Adequate organ function:
Adequate marrow function: neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
Adequate liver and kidney function: Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 2.5×ULN.; creatinine clearance rate ≥ 60 ml/min or creatinine of no more than 1.5 times the upper normal limit.
Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD,PhD | Contact | +86-20-87343361 | chenmy@sysucc.org.cn | |
| Rui You, MD,PhD | Contact | +86-13580439820 | yourui@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
| Second Affiliated Hospital, Sun Yat-Sen University | OTHER |
| The fifth Affiliated Hospital of Guangzhou Medcial University | OTHER_GOV |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Hunan Cancer Hospital | OTHER |
| Tongji Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Full course of PD-1/PD-L1 blockades | Drug | a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment. |
|
| Reduced-dose IMRT | Radiation | GTVnx:60Gy/30F/2.0Gy,CTV1:54Gy/30F/1.8Gy,CTV2:48Gy/30F/1.6Gy |
|
| Standard-dose IMRT | Radiation | GTVnx:69.96Gy/33Fr/2.12Gy;CTV1:60.60Gy/33Fr/1.82y;CTV2:54.12Gy/33Fr/1.64Gy |
|
| Concurrent Chemotherapy | Drug | Cisplatin 100mg/m2 every 3 weeks for 2 cycles |
|
| 3 years |
| Distant Metastasis-Free Survival (DMFS) | Defined as the time interval from randomisation to the date of first distant metastases. | 3 years |
| The proportion of patients with treatment related acute complications | The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria. | 1 year |
| The proportion of patients with treatment related late complications | The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria. | 3 years |
| 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 |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided