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

Jiangsu Cancer Hospital

Status and phase: Terminated; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01694576

JSCC-RCT01 (Other Identifier)

NPC-N23-RCT

Details and patient eligibility

About

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?

Full 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?

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Adjuvant chemotherapy with paclitaxel and nedaplatin

Experimental group

Description:

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

Treatment:

Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin

Observation

No Intervention group

Description:

Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation