Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Sponsor

Guangxi Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00778908

Collaborator

People's Hospital of Guangxi (Other), Guangxi Sci-Tech Office (Other)

120

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Radiation: Late-course accelerated hyperfractionated IMRT Drug: Concomitant cisplatin chemotherapy Radiation: Conventionally fractionated IMRT	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy	Radiation: Late-course accelerated hyperfractionated 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) 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
Other: B Conventionally fractionated IMRT with concomitant cisplatin chemotherapy	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.

Arm

Intervention/Treatment

Experimental: A

Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy

Radiation: Late-course accelerated hyperfractionated 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) 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

Other: B

Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

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.

Outcome Measures

Primary Outcome Measures

Local/regional control rate, Acute and late toxicities [2-Yr]

Secondary Outcome Measures

Overall survival rate [5-Yr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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