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The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.
Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen
Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Cisplatin 40mg/m2,weekly |
| |
| 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival, and distant metastases free survival | 3 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Kong, MD | Contact | 8621-64175590 | 3900 | konglinj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Kong, MD | Department of Radiation Oncology, Cancer Hospital, Fudan University | Principal Investigator |
| Chaosu Hu, MD | Department of Radiation Oncology, Cancer Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Cancer Hospital, Fudan University | Recruiting | Shanghai | 200032 | 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 |
|---|---|
| D002945 | Cisplatin |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Radiation |
3D-CRT or IMRT |
|
| 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 |
| D011881 |
| Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |