Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

This study has been completed.
Sponsor:
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
  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
  1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease
  2. 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
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:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
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 April 16, 2014