A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced 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 prophylatctic cranial irradiation 5 days a week for 3 weeks.
- Arm II: Patients undergo observation. Quality of life is assessed at baseline and at
months 6, 12, 24, 36, and 48.
Patients are followed 3 months during the first year, every 6 months for 2-3 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for
this study within 36 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of stage IIIA or IIIB non-small cell lung cancer
- Complete response, partial response, or stable disease after definitive
locoregional therapy (thoracic radiotherapy) with or without systemic
chemotherapy and/or surgery (chemotherapy alone is not considered 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Elizabeth M. Gore, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical College of Wisconsin
Authority:
United States: Federal Government
Study ID:
CDR0000257200
NCT ID:
NCT00048997
Start Date:
September 2002
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| MetroWest Medical Center - Framingham Union Hospital | Framingham, Massachusetts 01702 |
| Resurrection Medical Center | Chicago, Illinois 60631 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale, Arizona 85251 |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
| Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |
| Shore Regional Cancer Center at Memorial Hospital - Easton | Easton, Maryland 21601 |
