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A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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 CenterWilkes-Barre, Pennsylvania  18711
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Arizona Oncology Services FoundationPhoenix, Arizona  85013
MetroWest Medical Center - Framingham Union HospitalFramingham, Massachusetts  01702
Resurrection Medical CenterChicago, Illinois  60631
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260
Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona  85251
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240
Shore Regional Cancer Center at Memorial Hospital - EastonEaston, Maryland  21601