Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
18 Years
70 Years
Both
Nasopharyngeal Carcinoma
Trial Information
Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of
early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease
had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered
concurrently with radiation therapy, has been adopted as standard treatment for locally
advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been
prospectively studied. In the present trial, we hope to assess the value of concurrent
chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
3 and 5 years
Safety Issue:
Yes
Principal Investigator
Lin Kong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Radiation Oncology, Cancer Hospital, Fudan University
Authority:
China: Ethics Committee
Study ID:
NPC-0701
NCT ID:
NCT00817258
Start Date:
January 2007
Completion Date:
December 2009
Related Keywords:
- Nasopharyngeal Carcinoma
- Phase 2 Clinical Trial
- NPC
- radiation therapy
- chemotherapy
- Carcinoma
- Nasopharyngeal Neoplasms
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