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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01158170

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: Prophylactic cranial irradiation Drug: Erlotinib /Gefitinib	Phase 3

Detailed Description

OBJECTIVES:

Primary

Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.

Secondary

Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.

Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.

After completion of study therapy, patients are followed up periodically.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prophylactic cranial irradiation Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.	Radiation: Prophylactic cranial irradiation 25GY/10fraction Other Names: PCI Drug: Erlotinib /Gefitinib Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity Other Names: EGFR-TKI
Active Comparator: Conctrol Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity	Drug: Erlotinib /Gefitinib Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity Other Names: EGFR-TKI

Arm

Intervention/Treatment

Experimental: prophylactic cranial irradiation

Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.

Radiation: Prophylactic cranial irradiation

25GY/10fraction

Other Names:

PCI

Drug: Erlotinib /Gefitinib

Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity

Other Names:

EGFR-TKI

Active Comparator: Conctrol

Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity

Drug: Erlotinib /Gefitinib

Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity

Other Names:

EGFR-TKI

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

overall survival [baseline to date of death from any cause]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients were required to have histologically or cytologically documented
NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
No previous history of radiotherapy and surgery of brain
good response( CR/PR) to Erlotinib or Gefitinib.
Agree to radiotherapy
age > 18 and <75 years,ECOG performance status 1 or less
Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
Have provided informed consent