Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC) (TPF for NPC)
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|ClinicalTrials.gov Identifier: NCT00817583|
Recruitment Status : Unknown
Verified January 2009 by Fudan University.
Recruitment status was: Not yet recruiting
First Posted : January 6, 2009
Last Update Posted : January 27, 2009
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.
The third objective of this study is to evaluate who may benifit from this treatment regimen.
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: docetaxel, cisplatin, fluorouracil Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||July 2011|
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
Drug: docetaxel, cisplatin, fluorouracil
neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
concurrent chemotherapy:cisplatin 40 mg/m2 weekly
Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
- overall survival [ Time Frame: 3 and 5 years ]
- distant metastases free survival , and disease-free survival [ Time Frame: 3 and 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817583
|Contact: ChaoSu HU, M.D.||86-21-64175590 ext firstname.lastname@example.org|
|Contact: XiaoShen WANG, M.D.||86-21-64175590 ext email@example.com|
|Department of Radiation Oncology, Cancer Hospital, Fudan University|
|Shanghai, Shanghai, China, 200032|
|Contact: Xiaoshen Wang, M.D. 86-21-64175590 ext 6516 firstname.lastname@example.org|
|Contact: TingTing Xu, M.D. 86-21-64175590 ext 6511 email@example.com|
|Principal Investigator:||XiaoShen WANG, M.D.||Department of Radiation Oncology, Cancer Hospital, Fudan University|
|Study Chair:||ChaoSu HU, M.D.||Department of Radiation Oncology, Cancer Hospital, Fudan University|
|Principal Investigator:||ChunYing Shen, M.D.||Department of Radiation Oncology, Cancer Hospital, Fudan University|
|Principal Investigator:||HongMei Ying, M.D.||Department of Radiation Oncology, Cancer Hospital, Fudan University|