Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
  • Compare the quality of life and survival of these patients.
  • Determine the toxicity of this regimen in these patients.
  • Determine the health economics associated with this study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.
  • Arm II: Patients receive no further therapy after completion of prior chemotherapy.

Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Ghent, Belgium, B-9000
        • Universiteit Gent
      • Haine Saint Paul, Belgium, 7100
        • Hôpital de Jolimont
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Liege, Belgium, B 4000
        • Clinique Saint-Joseph
      • Liege, Belgium, 4000
        • Centre Hospitalier Regional De La Citadelle
  • Cyprus
      • Nicosia, Cyprus, 2006 Strovolos
        • Bank Of Cyprus Oncology Centre
  • Egypt
      • Cairo, Egypt
        • National Cancer Institute of Egypt
  • France
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Hamburg, Germany, D-20246
        • Universitaetsklinikum Hamburg-Eppendorf
  • Hungary
      • Kaposvar, Hungary, 7400
        • University of Kaposvar
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Italy
      • Cuneo, Italy, 12100
        • Ospedale Santa Croce
      • Genoa (Genova), Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Parma, Italy, 43100
        • Azienda Ospedaliera Di Parma
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Arnhem, Netherlands, 6815 AD
        • Arnhems Radiotherapeutisch Instituut
      • Deventer, Netherlands, 7400 AC
        • Radiotherapeutisch Instituut-(Riso)
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen
      • Leeuwarden, Netherlands, 8934 AD
        • Radiotherapeutisch Instituut Friesland
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Nijmegen Cancer Center at Radboud University Medical Center
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
      • Rotterdam, Netherlands, 3015 GJ
        • Erasmus MC - Sophia Children's Hospital
      • Tilburg, Netherlands, 5042 SB
        • Dr. Bernard Verbeeten Instituut
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
  • Turkey
      • Istanbul, Turkey, 81190
        • Marmara University Hospital
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital
      • Leeds, England, United Kingdom, LS16 6QB
        • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Shrewsbury, England, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend NHS Trust Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital
      • Gwent, Wales, United Kingdom
        • Nevill Hall Hospital
      • Newport Gwent, Wales, United Kingdom, NP9 2UB
        • Royal Gwent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Cytologically or histologically confirmed small cell lung cancer

    • Documented extensive disease before the initiation of chemotherapy

  • Responsive disease after 4 to 6 courses of initial chemotherapy

    • No more than 5 weeks since completion of prior chemotherapy
  • No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • No prior radiotherapy to the brain
  • No prior radiotherapy to the head and neck

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months

Secondary Outcome Measures

Outcome Measure
Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months
Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months
Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: B.J. Slotman, PhD, MD, Free University Medical Center
  • Study Chair: Pieter E. Postmus, MD, Free University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-22993-08993
  • EORTC-RA-22993
  • EORTC-LCG-08993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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