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| ID | Type | Description | Link |
|---|---|---|---|
| JSCC-RCT01 | Other Identifier | Department of Radiotherapy,Jiangsu Cancer Hospital |
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slow patient enrollment
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By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant chemotherapy with paclitaxel and nedaplatin | Experimental | Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation |
|
| Observation | No Intervention | Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant chemotherapy with paclitaxel and nedaplatin | Drug | Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| treatment toxicity based on a CTCAE3.0 grading system | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| distant metastasis free survival | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xia He, M.D. and PhD | Department of Radiotherapy,Jiangsu Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D017239 | Paclitaxel |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D043823 | Taxoids |
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|
| 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 |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |