Status:
UNKNOWN
Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Roche Pharma AG
Pfizer
Conditions:
Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite...
Detailed Description
Concurrent Chemoradiation therapy is widely accepted as a standard treatment of locally advanced unresectable stage III NSCLC. When compared with the result of radiation therapy alone of CALGB 8433 tr...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC: it is recommended to obtain adequate tissue samples for EGFR mutation analysis.
- Unresectable stage IIIA (N2) or stage IIIB NSCLC defined as:unresectability confirmed by Surgeon /Stage IIIa T1-3 N2/Stage IIIb T1-4 N3/Stage IIIb T4 N2
- Age 18 years over.
- ECOG performance status of 0 or 1.
- Tumor work-up: within 4 weeks prior 1st day of treatment: chest X-ray; CT of chest, liver, and adrenal glands; bone scan; brain MRI
- Measurable or un-measurable disease (according to RECIST criteria), documented by CT, MRI, X-ray, or physical exam, as appropriate.
- Hematology (within 1 week before 1st day of treatment)Absolute Neutrophil Count ³2.0 x 109/L; Platelet ³100 x 109/L; Hemoglobin ³10 g/dl
- Liver function test (within 1 week before 1st day of treatment)Serum bilirubin £1 x UNL; AST \& ALT £2.5 x UNL
- Renal function (within 1 week before 1st day of treatment)Serum creatinine £1 x UNL. In case of borderline value, 24h creatinine clearance should be \> 60 mL/min.
- Pulmonary function (within 4 weeks before 1st day of treatment)FEV1 ³ 1 Liter
- ECG without significant abnormalities within 4 weeks before 1st day of treatment.
- Written informed consent.
Exclusion
- T4 with malignant pleural effusion.
- Any prior therapy (chemotherapy, immunotherapy, biologic therapy such as EGFR-targeted therapy, radiotherapy) for lung cancer.
- History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
- Unintended weight loss \> 10% within the last 3 months.
- Other serious concomitant illness or medical conditions:
- Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia.
- History of significant neurological or psychiatric disorders including dementia or seizures.
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication of corticosteroid therapy.
- Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- Pregnant or lactating women-Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concurrent use of phenytoin, carbamazepin, barbiturates, or rifampin.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequence of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00620269
Start Date
February 1 2008
End Date
March 1 2015
Last Update
November 7 2011
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyenggi-do, South Korea, 411-769