Brief Title
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
Official Title
Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
Brief Summary
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
Detailed Description
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
treatment toxicity based on a CTCAE3.0 grading system
Secondary Outcome
progress free survival
Condition
Nasopharyngeal Carcinoma
Intervention
Adjuvant chemotherapy with paclitaxel and nedaplatin
Study Arms / Comparison Groups
Adjuvant chemotherapy with paclitaxel and nedaplatin
Description: Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
September 2012
Completion Date
October 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: 1. pathologically confirmed untreated NPC patients staged N2-3M0 2. age: 18y - 65y 3. with MRI examinations 4. ECOG≤2 5. with written consent Exclusion Criteria: 1. without a second cancer 2. pregnancy 3. with other severe diseases(blood,liver ,kidney or heart diseases) 4. could not staged properly 5. without written consent
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xia He, M.D. and PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01694576
Organization ID
NPC-N23-RCT
Secondary IDs
JSCC-RCT01
Responsible Party
Principal Investigator
Study Sponsor
Jiangsu Cancer Institute & Hospital
Study Sponsor
Xia He, M.D. and PhD, Principal Investigator, Department of Radiotherapy,Jiangsu Cancer Hospital
Verification Date
June 2015