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Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT00778908 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-08-21

No results posted yet for this study

Summary

Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

Late-course accelerated hyperfractionated IMRT

1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease 2. IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.

DRUG

Concomitant cisplatin chemotherapy

cisplatin:40mg/m2 weekly infusion for 6 weeks

RADIATION

Conventionally fractionated IMRT

IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.

Sponsors & Collaborators

  • People's Hospital of Guangxi Zhuang Autonomous Region

    collaborator OTHER

  • Guangxi Sci-Tech Office

    collaborator UNKNOWN

  • Guangxi Medical University

    lead OTHER

Principal Investigators

  • Heming Lu, MD · Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region

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
2008-01-31
Primary Completion
2011-01-31
Completion
2011-12-31

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 NCT00778908 on ClinicalTrials.gov