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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT01158170
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Prophylactic cranial irradiation — RADIATION
    25GY/10fraction
  • Erlotinib /Gefitinib — DRUG
    Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity

Study Details

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

Key Dates

First listed
Jul 8, 2010
Start date
Jun 30, 2010
Status verified
Jul 2010
Primary completion
May 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: prophylactic cranial irradiation
    Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
  • Active Comparator: Conctrol
    Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity

Primary Outcome Measure

The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) [ Time Frame: 2.5years ]

Central Contacts

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