Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00048997
First received: November 12, 2002
Last updated: September 30, 2014
Last verified: September 2014

November 12, 2002
September 30, 2014
September 2002
December 2008   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.
Not Provided
Complete list of historical versions of study NCT00048997 on ClinicalTrials.gov Archive Site
  • Neuropsychological Impact of Prophylactic Cranial Irradiation (PCI) [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]
  • Impact of PCI on Quality of Life [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]
  • Impact of PCI on Incidence of CNS Metastases [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

OBJECTIVES:

  • Determine whether prophylactic cranial irradiation improves survival after effective locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer.
  • Determine the neuropsychologic impact of this therapy in these patients.
  • Assess quality of life of patients receiving this therapy.
  • Determine the impact of this therapy on the incidence of CNS metastases in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.
  • Arm II: Patients undergo observation.

Patients are followed 3 months during the first year, every 6 months for 2-3 years and then annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and 48.

PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Radiation: Radiation therapy
    PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
  • Other: Observation
  • Experimental: Prophylactic cranial irradiation (PCI)
    Radiation therapy
    Intervention: Radiation: Radiation therapy
  • Observation
    Observation
    Intervention: Other: Observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
356
Not Provided
December 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIIA or IIIB non-small cell lung cancer

    • Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))

      • No more than 16 weeks since prior therapy
  • No progressive disease
  • No extracranial distant metastatic disease
  • No suspicion of CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other malignancy within the past 3 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior cranial irradiation

Surgery

  • See Disease Characteristics

Other

  • Recovered from all prior therapies
  • No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00048997
RTOG-0214, CDR0000257200, ECOG-RTOG-0214
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Elizabeth M. Gore, MD Medical College of Wisconsin
Study Chair: James A. Bonner, MD University of Alabama at Birmingham
Radiation Therapy Oncology Group
September 2014

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