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Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

NCT02143388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-08-31

No results posted yet for this study

Summary

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

Conditions

  • Local Advanced High Risk Nasopharyngeal Carcinoma

Interventions

DRUG

IMRT combine with cisplatin concurrent chemotherapy

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

DRUG

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Sponsors & Collaborators

  • Jiangxi Provincial Cancer Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • National Cancer Centre, Singapore

    collaborator OTHER

  • Zhao Chong

    lead OTHER

Principal Investigators

  • zhao chong, M.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-07-27
Completion
2022-08-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143388 on ClinicalTrials.gov