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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Jiangxi Provincial Cancer Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Affiliated Hospital of Jiangnan University |
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The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy+IMRT+adjuvant chemotherapy | Experimental | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles. |
|
| Induction chemotherapy+IMRT and concurrent cisplatin | Active Comparator | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 30 mg/m² every week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine and cisplatin (Induction and adjuvant chemotherapy) | Drug | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first. | 3-year |
| Grade III or more mucositis | Grade III or more mucositis during radiotherapy | From the start of radiotherapy to 30 days after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is calculated from randomization to death from any cause. | 3-year |
| Locoregional failure-free survival | Locoregional failure-free survival is calculated from randomization to the first locoregional failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaosu Hu, MD,PhD | Contact | +86 18017312302 | hucsu62@yahoo.com | |
| Xiayun He, MD | Contact | +86 18017312167 | hexiayun1962@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705321 | Derived | Xue F, Ou D, Xie C, Lin S, Li J, Chen X, Zhang F, Ying H, Lu X, Shen C, Xu T, Ou X, Li W, Zhou X, Du C, Zhou C, Hu C, He X. Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2025 Jul 24;11(9):1011-20. doi: 10.1001/jamaoncol.2025.2191. Online ahead of print. |
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| OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
Stratified by stage
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| IMRT | Radiation | Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor |
|
| gemcitabine and cisplatin (Induction chemotherapy) | Drug | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy. |
|
| IMRT and concurrent cisplatin | Radiation | Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week. |
|
| 3-year |
| Distant failure-free survival | Distant failure-free survival is calculated from randomization to the first remote failure. | 3-year |
| Short-term treatment response | Treatment response after induction chemotherapy, IMRT and completion of treatment. | Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy. |
| Number of participants with adverse events | Incidence of acute and late toxicity | up to 3 years |
| Quality of Life | Use EORTC QLQ-HN35. | up to 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 |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D020360 | Neoadjuvant Therapy |
| D017024 | Chemotherapy, Adjuvant |
| D060828 | Induction Chemotherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D012074 | Remission Induction |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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