Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer

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

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Erlotinib Hydrochloride; Gefitinib

Criteria

Inclusion Criteria:

1. Patients were required to have histologically or cytologically documented

2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy

3. No previous history of radiotherapy and surgery of brain

4. good response( CR/PR) to Erlotinib or Gefitinib.

5. Agree to radiotherapy

6. age > 18 and <75 years,ECOG performance status 1 or less

7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions

8. Have provided informed consent

Exclusion Criteria:

1. Seizure cannot be controled by the drugs

2. Combined with other disease of the brain such as tumour or infarction

3. Hypersensitivity to MR enhancer -