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Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Late-course accelerated hyperfractionated IMRT
Concomitant cisplatin chemotherapy
Conventionally fractionated IMRT
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Locally advanced disease, Intensity-modulated radiation therapy, Accelerated hyperfractionation, Concomitant boost radiation therapy, Concurrent chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • People's Hospital of Guangxi Zhuang Autonomous Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

A

B

Arm Description

Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy

Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

Outcomes

Primary Outcome Measures

Local/regional control rate, Acute and late toxicities

Secondary Outcome Measures

Overall survival rate

Full Information

First Posted
October 22, 2008
Last Updated
August 17, 2012
Sponsor
Guangxi Medical University
Collaborators
People's Hospital of Guangxi, Guangxi Sci-Tech Office
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1. Study Identification

Unique Protocol Identification Number
NCT00778908
Brief Title
Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
Collaborators
People's Hospital of Guangxi, Guangxi Sci-Tech Office

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, Locally advanced disease, Intensity-modulated radiation therapy, Accelerated hyperfractionation, Concomitant boost radiation therapy, Concurrent chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
Arm Title
B
Arm Type
Other
Arm Description
Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Late-course accelerated hyperfractionated IMRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Concomitant cisplatin chemotherapy
Intervention Description
cisplatin:40mg/m2 weekly infusion for 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Conventionally fractionated IMRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local/regional control rate, Acute and late toxicities
Time Frame
2-Yr
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
5-Yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heming Lu, MD
Organizational Affiliation
Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region
Official's Role
Study Chair
Facility Information:
Facility Name
People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.gxmu.edu.cn/
Description
Guangxi Medical University

Learn more about this trial

Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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