Overview

Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy. Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Cisplatin
Criteria
Inclusion Criteria:

- Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated
carcinoma of the nasopharynx.

- Stage II disease (T1-2; N1; M0)

- 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.