Overview

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