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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-10-31

Brief Summary

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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?

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Detailed Description

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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?

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adjuvant chemotherapy with paclitaxel and nedaplatin

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

Group Type EXPERIMENTAL

Adjuvant chemotherapy with paclitaxel and nedaplatin

Intervention Type DRUG

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

Observation

Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjuvant chemotherapy with paclitaxel and nedaplatin

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

Intervention Type DRUG

Other Intervention Names

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Adjuvant chemotherapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No