Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified June 2012 by Zhejiang Cancer Hospital
Sponsor:
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01514877
First received: January 17, 2012
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy. The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Metastatic Cancer |
Drug: Icotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Zhejiang Cancer Hospital:
Primary Outcome Measures:
- partial response rate of intracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]Partial response rate of intracranial lesions will be measured.
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]Progression-free survival will be evaluated
- overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]Overall survival will be evaluated
- partial response rate of extracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]Partial response rate of extracranial lesions will be evaluated
- Health-related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Health-related quality of life will be measured
- safety and tolerability [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects
- the relationship between Progression-Free Survival and EGFR mutation status [ Time Frame: 4 years ] [ Designated as safety issue: No ]The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Icotinib plus Whole Brain Radiotherapy |
Drug: Icotinib
Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cytologic or histological diagnosis of non-small cell lung cancer
- Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
- Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
- Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
- Doctors consider the patient will benefit from WBRT
- No prior brain radiotherapy
- ECOG performance status 0-2
- age:18-75 years
- Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
- Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
- Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
Exclusion Criteria:
- Prior brain radiation therapy
- Solitary brain metastasis according to Magnetic resonance imaging (MRI)
- Mort than 3 extracranial organs have metastatic lesions
- Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
- pregnant or breast feeding women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514877
Contacts
| Contact: Yun Fan, MD | 0086-571-88122192 | fanyun@csco.org.cn |
Locations
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Yun Fan, MD 0086-571-88122192 fanyun@csco.org.cn | |
| Principal Investigator: Yun Fan, MD | |
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
| Principal Investigator: | Yun Fan, MD | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Zhejiang Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01514877 History of Changes |
| Other Study ID Numbers: | ZhejiangCH-LCBM-1201 |
| Study First Received: | January 17, 2012 |
| Last Updated: | June 7, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang Cancer Hospital:
|
tumors metastatic to brain non-small cell lung cancer Icotinib |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Bronchogenic Bronchial Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013