Clinical trial NCT01158170: Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: nonsmall cell lung cancer
brain metastasis
prophylactic cranial irradiation
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
timeFrame: 2.5years
Secondary outcomes:
measure: overall survival
timeFrame: baseline to date of death from any cause
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Shenglin Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: