Status:
COMPLETED
The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Intensity-modulated radiation therapy (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin and paclitaxel) is ...
Detailed Description
Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond all concurrent chem...
Eligibility Criteria
Inclusion
- biopsy-proved NPC
- N3 or T4N2 or multiple lymphnodes involved with at least one mass 4 cm or more in maximal diameter according to 7th UICC Staging
- provide written informed consent
- Kps\>70
- no dostant metastasis
- Life expectancy≥6 months
- Adequate renal function, defined as follows: Serum creatinine \< 2 x institutional upper limitof normal(ULN) within 2 weeks prior to registration or; creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CCrmale)
- The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin.
Exclusion
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01797900
Start Date
March 1 2013
End Date
September 1 2014
Last Update
September 10 2014
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021