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Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT04414566 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2020-06-04

No results posted yet for this study

Summary

The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

RADIATION

IMRT

Intensity modulated-radiotherapy (IMRT) is given as 2.0 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.

RADIATION

IMRT and concurrent cisplatin

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 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, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng, MD, PhD · West China Hospital

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
2020-06-01
Primary Completion
2022-05-30
Completion
2025-05-30

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 NCT04414566 on ClinicalTrials.gov