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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

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


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?


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

treatment toxicity based on a CTCAE3.0 grading system

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Xia He, M.D. and PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiotherapy,Jiangsu Cancer Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NPC-N23-RCT

NCT ID:

NCT01694576

Start Date:

September 2012

Completion Date:

October 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma staged N2-3M0
  • Adjuvant chemotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

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