Overview

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