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Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT00778908

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Keywords

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Nasopharyngeal carcinoma Locally advanced disease Intensity-modulated radiation therapy Accelerated hyperfractionation Concomitant boost radiation therapy Concurrent chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy

Group Type EXPERIMENTAL

Late-course accelerated hyperfractionated IMRT

Intervention Type RADIATION

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.

Concomitant cisplatin chemotherapy

Intervention Type DRUG

cisplatin:40mg/m2 weekly infusion for 6 weeks

B

Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

Group Type OTHER

Concomitant cisplatin chemotherapy

Intervention Type DRUG

cisplatin:40mg/m2 weekly infusion for 6 weeks

Conventionally fractionated IMRT

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Concomitant cisplatin chemotherapy

cisplatin:40mg/m2 weekly infusion for 6 weeks

Intervention Type DRUG

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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
* According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
* Age between 18-70
* Karnofsky performance status ≥70
* WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
* Without radiotherapy or chemotherapy
* Signed study-specific consent form prior to study entry

Exclusion Criteria

* Patients with distant metastasis
* Pregnant or lactating women
* The presence of uncontrolled life-threatening illness
* Patients who received radiotherapy or chemotherapy previously
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Guangxi Sci-Tech Office

UNKNOWN

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Heming Lu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heming Lu, MD

Role: STUDY_CHAIR

Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region

Locations

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People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status

Countries

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China

Related Links

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http://www.gxsti.net.cn/GXSAT/Default.shtml

Guangxi Sci-Tech Office

http://www.gxmu.edu.cn/

Guangxi Medical University

Other Identifiers

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GUIKEGONG-0816004-40

Identifier Type: -

Identifier Source: org_study_id