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

Radiation Therapy Oncology Group

Status and phase

Completed

Phase 3

Conditions

Lung Cancer

Treatments

Other: Observation

Radiation: Radiation therapy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00048997

ECOG-RTOG-0214

RTOG-0214

CDR0000257200

Details and patient eligibility

About

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.

Full description

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.

Enrollment

356 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 (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