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NCT01694576 Clinical Trial

NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01694576
Other study ID # NPC-N23-RCT
Secondary ID JSCC-RCT01
Status Terminated
Phase Phase 2
First received September 17, 2012
Last updated June 12, 2015
Start date September 2012
Est. completion date October 2015

Study information
Verified date June 2015
Source Jiangsu Cancer Institute & Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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?

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?

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Adjuvant chemotherapy with paclitaxel and nedaplatin
Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation

Locations
Country Name City State
China Jiangsu Cancer Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other distant metastasis free survival 24 months No
Primary treatment toxicity based on a CTCAE3.0 grading system 6 months Yes
Secondary progress free survival 24 months No
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