Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage Ⅲ treated with this regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• 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 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