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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Outcome Measure:

Time to symptomatic brain metastases

Safety Issue:

No

Principal Investigator

Chang Geol Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University

Authority:

Unspecified

Study ID:

CDR0000639096

NCT ID:

NCT00955695

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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