Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
This study has been completed.
Sponsor:
Guangxi Medical University
Collaborators:
People's Hospital of Guangxi
Guangxi Sci-Tech Office
Information provided by (Responsible Party):
Heming Lu, People's Hospital of Guangxi
ClinicalTrials.gov Identifier:
NCT00778908
First received: October 22, 2008
Last updated: August 17, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Radiation: Late-course accelerated hyperfractionated IMRT Drug: Concomitant cisplatin chemotherapy Radiation: Conventionally fractionated IMRT |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Guangxi Medical University:
Primary Outcome Measures:
- Local/regional control rate, Acute and late toxicities [ Time Frame: 2-Yr ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall survival rate [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy
|
Radiation: Late-course accelerated hyperfractionated IMRT
cisplatin:40mg/m2 weekly infusion for 6 weeks
|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778908
Locations
| China, Guangxi | |
| People's Hospital of Guangxi Zhuang Autonomous Region | |
| Nanning, Guangxi, China, 530021 | |
Sponsors and Collaborators
Guangxi Medical University
People's Hospital of Guangxi
Guangxi Sci-Tech Office
Investigators
| Study Chair: | Heming Lu, MD | Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region |
More Information
Additional Information:
No publications provided
| Responsible Party: | Heming Lu, Associate Professor, People's Hospital of Guangxi |
| ClinicalTrials.gov Identifier: | NCT00778908 History of Changes |
| Other Study ID Numbers: | GUIKEGONG-0816004-40 |
| Study First Received: | October 22, 2008 |
| Last Updated: | August 17, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Guangxi Medical University:
|
Nasopharyngeal carcinoma Locally advanced disease Intensity-modulated radiation therapy |
Accelerated hyperfractionation Concomitant boost radiation therapy Concurrent chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013