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Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Nasopharyngeal Carcinoma

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Trial Information

Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local/regional control rate, Acute and late toxicities

Outcome Time Frame:

2-Yr

Safety Issue:

Yes

Principal Investigator

Heming Lu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region

Authority:

China: Ethics Committee

Study ID:

GUIKEGONG-0816004-40

NCT ID:

NCT00778908

Start Date:

January 2008

Completion Date:

December 2011

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma
  • Locally advanced disease
  • Intensity-modulated radiation therapy
  • Accelerated hyperfractionation
  • Concomitant boost radiation therapy
  • Concurrent chemotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

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