Status:
UNKNOWN
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectabilit...
Detailed Description
Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles Arm 2. (preoperative chemoradiotherapy) Paclitaxel ...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of non-small cell lung cancer.
- Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on Cancer (AJCC), with none of the mediastinal lymph nodes \> 3 cm in largest diameter.
- Tumor amenable to surgical resection.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
- Performance status of 0-1 on ECOG scale.
- At least 18 years old.
- Patient compliance that allows adequate follow-up.
- Medical fitness of patients adequate for radical NSCLC surgery.
- Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
- Signed informed consent from patient or legal representative.12. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.
Exclusion
- Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
- Active uncontrolled infection.
- Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
- Significant neurological or mental disorder.
- Second primary malignancy.
- Pregnant or nursing.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00452803
Start Date
April 1 2006
End Date
December 1 2012
Last Update
July 12 2010
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 411-769