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

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00005062
First received: April 6, 2000
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Incidence of brain metastases 2 years after randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival and disease-free survival 2 years after randomization [ Designated as safety issue: No ]
  • Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Study Start Date: September 1999
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • 70 and under

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior cerebrovascular disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • Concurrent thoracic radiotherapy allowed

Surgery:

  • Not specified

Other

  • No other concurrent antitumoral agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005062

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00005062     History of Changes
Other Study ID Numbers: CDR0000067664, FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004
Study First Received: April 6, 2000
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014