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Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

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ClinicalTrials.gov Identifier: NCT00005062
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 13, 2014
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission.
  • Evaluate the quality of life and late sequelae in this patient population treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose.

  • Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days).
  • Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center.

    • 18 fractions/24 days (conventional radiotherapy) OR
    • 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy.

Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter.

Patients are followed at least every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders
Study Start Date : September 1999
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of brain metastases 2 years after randomization

Secondary Outcome Measures :
  1. Overall survival and disease-free survival 2 years after randomization
  2. Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
  3. Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven limited stage small cell lung cancer
  • Complete response to induction therapy (at least on chest x-ray)
  • Normal brain CT scan or MRI less than 1 month prior to study
  • No metastases (including ipsilateral lung metastases and malignant pleural effusion)



  • 70 and under

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior cerebrovascular disease


  • No epilepsy requiring permanent oral medication
  • No other prior malignancy except skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed


  • Concurrent thoracic radiotherapy allowed


  • Not specified


  • No other concurrent antitumoral agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005062

  Show 93 Study Locations
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
European Organisation for Research and Treatment of Cancer - EORTC
OverallOfficial: Cecile Le Pechoux, MD Gustave Roussy, Cancer Campus, Grand Paris
OverallOfficial: Suresh Senan Free University Medical Center

ClinicalTrials.gov Identifier: NCT00005062     History of Changes
Other Study ID Numbers: CDR0000067664
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms