Status:
UNKNOWN
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
Lead Sponsor:
Fudan University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and c...
Detailed Description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In t...
Eligibility Criteria
Inclusion
- -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- Stage Ⅲ, IVa and IVb 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.
- the primary tumor or involved lymph node must be more than 2CM in diameter.
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00817583
Start Date
January 1 2009
End Date
July 1 2011
Last Update
January 27 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Radiation Oncology, Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032