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NCT Number: NCT00778908

Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late-course accelerated hyperfractionated IMRT

Radiation
  • 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.

Concomitant cisplatin chemotherapy

Drug

cisplatin:40mg/m2 weekly infusion for 6 weeks

Conventionally fractionated IMRT

Radiation

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 outcomes

  1. Local/regional control rate, Acute and late toxicities

    Time frame: 2-Yr

Secondary outcomes

  1. Overall survival rate

    Time frame: 5-Yr

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Collaborators

  • Guangxi Sci-Tech Office
  • People's Hospital of Guangxi Zhuang Autonomous Region

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 24, 2008
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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