Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy
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?
Interventions
DRUGAdjuvant chemotherapy with paclitaxel and nedaplatin
Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Sponsors
Jiangsu Cancer Institute & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment toxicity based on a CTCAE3.0 grading system | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival | 24 months |
Other
| Measure | Time frame |
|---|---|
| distant metastasis free survival | 24 months |
Countries
China
Outcome results
None listed