Status:
UNKNOWN
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the tolerance and overall survival in patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation. Secondary obje...
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 t...
Eligibility Criteria
Inclusion
- Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
- Stage Ⅲ 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00816855
Start Date
February 1 2007
End Date
June 1 2010
Last Update
January 5 2009
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Hospital, Fudan University
Shanghai, China, 200032