Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
August 17, 2012 updated by: Heming Lu, Guangxi Medical University
Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangxi
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Nanning, Guangxi, China, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
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cisplatin:40mg/m2 weekly infusion for 6 weeks
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Other: B
Conventionally fractionated IMRT with concomitant cisplatin chemotherapy
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cisplatin:40mg/m2 weekly infusion for 6 weeks
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Local/regional control rate, Acute and late toxicities
Time Frame: 2-Yr
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2-Yr
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival rate
Time Frame: 5-Yr
|
5-Yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Heming Lu, MD, Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 22, 2008
First Submitted That Met QC Criteria
October 22, 2008
First Posted (Estimate)
October 24, 2008
Study Record Updates
Last Update Posted (Estimate)
August 21, 2012
Last Update Submitted That Met QC Criteria
August 17, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- GUIKEGONG-0816004-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.