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Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era

NCT02633202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-04-24

No results posted yet for this study

Summary

Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above,the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

IMRT

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.20 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor

DRUG

Cisplatin

concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles during IMRT

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Guilin Medical University, China

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Lei Chen, M.D. · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-08-04
Completion
2021-10-11

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT02633202 on ClinicalTrials.gov