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Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IInductive chemotherapy + concurrent cisplatin and IMRT | Experimental | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2,on day 1) repeated every weeks for 6 cycles during radiotherapy. |
|
| Inductive chemotherapy + IMRT | Experimental | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inductive chemotherapy + concurrent cisplatin and IMRT | Drug | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2,on day 1) repeated every week for 6 cycles during radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is calculated from randomization to death from any cause. | 3-year |
| Failure-free survival | Failure-free survival is calculated from the date of randomization to the date of the first failure at any site. | 3-year |
| Locoregional failure-free survival | the latency to the first local failure | 3-year |
| Distant failure-free survival | The latency to the first remote failure | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the complete response rates between the two treatment arms | 12 weeks after the completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of toxicity | Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janjun Li, M.D. | Contact | +86+13829745245 | lijj@sysucc.org.cn | |
| Lizhi Liu, M.D. | Contact | +86+13660528375 | liulizh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| yong Su, M.D. | Sun Yat-Sen University Cancer Center | Study Director |
| Janjun Li, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Lizhi Liu, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center,Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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|
|
| Inductive chemotherapy + IMRT | Drug | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT. |
|
|
| 3-years |
| Sun Yat-Sen University Cancer Center |
| Principal Investigator |
| State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University | Not yet recruiting | Guangzhou | 510060 | China |
|
| 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 |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| 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 |
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