Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: Prophylactic cranial irradiation Drug: Erlotinib /Gefitinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) [ Time Frame: 2.5years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: PCI
Drug: Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Name: 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 Name: EGFR-TKI
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer -
Contacts and Locations| Contact: Shenglin Ma, MD | +8657188122568 | mashenglin@medmail.com.cn |
| Contact: Yaping Xu, MD | +8657188122082 | xuyaping1207@gmail.com |
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Shenglin MA, MD +8657188122568 mashenglin@medmail.com.cn | |
| Contact: Yaping Xu, MD +8657188122082 xuyaping1207@gmail.com | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: XuYa ping, MD 0086-571-88122082 xuyaping1207@gmail.com | |
| Principal Investigator: | Shenglin Ma, MD | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Shenglin Ma, Zhejiang Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01158170 History of Changes |
| Other Study ID Numbers: | ZhejiangCH06 |
| Study First Received: | June 23, 2010 |
| Last Updated: | July 6, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Zhejiang Cancer Hospital:
|
nonsmall cell lung cancer brain metastasis prophylactic cranial irradiation |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Gefitinib Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013