Back to results

Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

erlotinib hydrochloride

gefitinib

questionnaire administration

quality-of-life assessment

whole-brain radiation therapy

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer
- Stage IIIB or IV disease
- Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
- Stable disease allowed provided 1 of the following criteria is met:
  - EGFR mutation (exon 19 or 21)
  - Having ≥ 2 of the following 3 factors:
    - Female
    - Never smoked
    - Histologically confirmed adenocarcinoma of the lung
No evidence of brain metastases by CT scan or MRI within the past 4 weeks

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,500/mm^3
Platelet count ≥ 150,000/mm^3
Bilirubin < 1.5 mg/dL
Serum creatinine < 1.5 times upper limit of normal

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Received 1 or 2 prior systemic chemotherapy regimens

Sites / Locations

Outcomes

Primary Outcome Measures

Time to symptomatic brain metastases

Secondary Outcome Measures

Progression-free survival

Overall survival

Safety and tolerability of prophylactic cranial radiotherapy

Psycho-neurological effects of prophylactic cranial radiotherapy

Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically

Full Information

NCT ID

NCT00955695

First Posted

August 7, 2009

Last Updated

August 1, 2013

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00955695

Brief Title

Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

5. 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.

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 are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups. Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically. After completion of study therapy, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Allocation

Randomized

Enrollment

242 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Intervention Type

Drug

Intervention Name(s)

gefitinib

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

whole-brain radiation therapy

Primary Outcome Measure Information:

Title

Time to symptomatic brain metastases

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Overall survival

Title

Safety and tolerability of prophylactic cranial radiotherapy

Title

Psycho-neurological effects of prophylactic cranial radiotherapy

Title

Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Stage IIIB or IV disease Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride Stable disease allowed provided 1 of the following criteria is met: EGFR mutation (exon 19 or 21) Having ≥ 2 of the following 3 factors: Female Never smoked Histologically confirmed adenocarcinoma of the lung No evidence of brain metastases by CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 1,500/mm^3 Platelet count ≥ 150,000/mm^3 Bilirubin < 1.5 mg/dL Serum creatinine < 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: See Disease Characteristics Received 1 or 2 prior systemic chemotherapy regimens

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chang Geol Lee, MD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

We'll reach out to this number within 24 hrs