Brief Title
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
Official Title
Phase ⅡStudy of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
Brief Summary
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
Detailed Description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival
benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never
been defined. In the present trail, we hope to assess the tolerance and survival benefits of
neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅣAB
NPC.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
overall survival
Secondary Outcome
distant metastases free survival, and disease-free survival
Condition
Nasopharyngeal Carcinoma
Intervention
docetaxel, cisplatin, fluorouracil
Study Arms / Comparison Groups
1
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
64
Start Date
February 2007
Completion Date
June 2010
Primary Completion Date
December 2009
Eligibility Criteria
Inclusion Criteria:
- Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated
carcinoma of the nasopharynx.
- Stage ⅣAB disease
- KPS >70
- Age between 18-70
- Patients should have adequate bone marrow function defined as an absolute peripheral
granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3
(pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper
normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
- No prior radiation treatment to the head and neck or any prior chemotherapy
- Patients with no prior malignancy (not include basal cell carcinoma of skin)
Exclusion Criteria:
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic
examinations.
- Prior radiotherapy to the head and neck region for any reason.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck
disease.
- Patients with previous or simultaneous primaries, excluding basal cell carcinoma or
squamous cell carcinoma of skin.
- Pregnant women
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Lin Kong, MD, 8621-64175590, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00816816
Organization ID
NPC-0703
Study Sponsor
Fudan University
Study Sponsor
Lin Kong, MD, Principal Investigator, Department of Radiation Oncology, Cancer Hospital, Fudan University
Verification Date
January 2009