Dexamethasone and Supportive Care With or Without Whole-Brain Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Spread to the Brain and Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other symptoms of inflammation and may be effective in treating some of the problems caused by cancer and cancer treatment. Supportive care improves the quality of life of patients with a serious or life-threatening disease, and prevents or treats symptoms of cancer, side effects of treatment, and other problems related to cancer or its treatment. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether dexamethasone given together with supportive care is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.

PURPOSE: This randomized phase III trial is studying dexamethasone and supportive care to see how well it works with or without whole-brain radiation therapy in improving the quality of life of patients with non-small cell lung cancer that has spread to the brain and cannot be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary non-small cell lung cancer

• Must have brain metastases confirmed by CT scan or MRI

• Unresectable disease OR surgery is deemed inappropriate

• The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined

• Any known certainty of the benefit or lack of benefit of WBRT is not allowed

PATIENT CHARACTERISTICS:

• No prior or concurrent uncontrolled illness that could preclude study treatment or comparisons

• Must be able to respond to weekly telephone assessment questions

PRIOR CONCURRENT THERAPY:

• More than 1 week since prior epidermal growth factor receptor inhibitors

• More than 1 month since prior chemotherapy

• More than 1 month since prior surgery for brain metastases

• No prior radiotherapy to the brain