Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00816816|
Recruitment Status : Unknown
Verified January 2009 by Fudan University.
Recruitment status was: Recruiting
First Posted : January 5, 2009
Last Update Posted : January 5, 2009
The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅣAB treated with this regimen
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: docetaxel, cisplatin, fluorouracil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase ⅡStudy of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma|
|Study Start Date :||February 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||June 2010|
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
Drug: docetaxel, cisplatin, fluorouracil
neoadjuvant chemotherapy: docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.
concurrent chemotherapy:cisplatin 40 mg/m2 weekly.
- 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): NCT00816816
|Contact: Lin Kong, MD||8621-64175590 ext email@example.com|
|Department of Radiation Oncology, Cancer Hospital, Fudan University||Recruiting|
|Shanghai, China, 200032|
|Contact: Jing Yuan 8621-64175590 ext 6511 firstname.lastname@example.org|
|Principal Investigator:||Lin Kong, MD||Department of Radiation Oncology, Cancer Hospital, Fudan University|
|Principal Investigator:||Chaosu Hu, MD||Department of Radiation Oncology, Cancer Hospital, Fudan University|