Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB 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 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

• 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 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