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)
18 Years
75 Years
Both
Non-small Cell Lung Cancer
Trial Information
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)
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.
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 -
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Outcome Time Frame:
2.5years
Safety Issue:
No
Principal Investigator
Shenglin Ma, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Zhejiang Cancer Hospital
Authority:
China: Ethics Committee
Study ID:
ZhejiangCH06
NCT ID:
NCT01158170
Start Date:
June 2010
Completion Date:
December 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- nonsmall cell lung cancer
- brain metastasis
- prophylactic cranial irradiation
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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