Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer

This study has been terminated.
(PI left institution)
Sponsor:
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00006344
First received: October 4, 2000
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year.


Condition Intervention Phase
Lung Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Phase III Dose Response Study of Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Enrollment: 0
Study Start Date: May 2000
Study Completion Date: December 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Compare the efficacy of low dose versus high dose prophylactic cranial irradiation in preventing brain metastases in patients with small cell carcinoma of the lung. II. Determine the neuropsychiatric status of these patients before and after treatment.

OUTLINE: This is a randomized, multicenter study. The right or left hemisphere of each patient's brain are randomized to one of two treatment arms. All patients receive whole brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. Arm I: Patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Arm II: Patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Patients with extensive disease may also receive thoracic radiotherapy, if not administered previously. Patients are followed at 1, 3, 6, 9, and 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 16-40 patients will be accrued for this study within 1-4 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma of the lung diagnosed within the past year Limited stage Must have completed prior chemotherapy with thoracic irradiation Extensive stage Must have completed prior chemotherapy with or without thoracic irradiation No more than 24 Gy of prior prophylactic cranial irradiation to the whole brain No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy within the past 3 years except the following: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

  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: NCT00006344

Locations
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Chair: Brian Kavanagh, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: Brian Kavanagh, MD, Virginia Commonwealth University/Massey Cancer Center
ClinicalTrials.gov Identifier: NCT00006344     History of Changes
Other Study ID Numbers: CDR0000068152, P30CA016059, MCV-MCC-9912-2A, NCI-V00-1613
Study First Received: October 4, 2000
Last Updated: February 23, 2010
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
limited stage small cell lung cancer
extensive stage small cell lung cancer

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

ClinicalTrials.gov processed this record on October 23, 2014