Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Late-course accelerated hyperfractionated IMRT; Drug: Concomitant cisplatin chemotherapy; Radiation: Conventionally fractionated IMRT

• Registration Number: NCT00778908
• Lead Sponsor: Guangxi Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-24
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Late-course accelerated hyperfractionated IMRT	Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
A	Concomitant cisplatin chemotherapy	Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
B	Concomitant cisplatin chemotherapy	Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
B	Conventionally fractionated IMRT	Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

Primary Outcome Measures

Name	Time	Method
Local/regional control rate, Acute and late toxicities	2-Yr

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	5-Yr

Trial Locations

Locations (1)

People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China