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

April 6, 2000
March 12, 2014
September 1999
December 2005   (final data collection date for primary outcome measure)
Incidence of brain metastases 2 years after randomization [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005062 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Cyprus,   United Kingdom,   France,   Australia,   Belgium,   Switzerland,   Israel,   Chile,   Greece,   Czech Republic,   South Africa,   Colombia,   Portugal,   Spain,   Poland,   Serbia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Brazil,   Romania,   United States,   Turkey,   Japan,   Italy,   China,   Korea, Republic of,   Germany
 
NCT00005062
CDR0000067664, FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
European Organisation for Research and Treatment of Cancer - EORTC
Investigator: Cecile Le Pechoux, MD Gustave Roussy, Cancer Campus, Grand Paris
Investigator: Suresh Senan Free University Medical Center
Gustave Roussy, Cancer Campus, Grand Paris
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP