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

Phase 2TerminatedNCT01694576

Jiangsu Cancer Institute & Hospital10 enrolled

Overview

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?

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma

Interventions

Adjuvant chemotherapy with paclitaxel and nedaplatinDRUG

Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

treatment toxicity based on a CTCAE3.0 grading system

Time frame: 6 months

Secondary Outcomes

progress free survival

Time frame: 24 months

Data from ClinicalTrials.gov

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