Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma
18 Years
70 Years
Both
Nasopharyngeal Carcinoma
Trial Information
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival
benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never
been defined. In the present trail, we hope to assess the tolerance and survival benefits
of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage Ⅲ
NPC.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/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-0702
NCT ID:
NCT00816855
Start Date:
February 2007
Completion Date:
June 2010
Related Keywords:
- Nasopharyngeal Carcinoma
- Phase 2 Clinical Trial
- NPC
- neoadjuvant chemotherapy
- concurrent chemoradiation
- Carcinoma
- Nasopharyngeal Neoplasms
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