Pre-operative Chemotherapy Versus Concurrent Chemoradioth... | NCT00452803 | Trialant
NCT00452803
Sponsor
National Cancer Center, Korea
Status
Unknown status
Last Update Posted
Jul 12, 2010Estimated
Enrollment
102Estimated
Phase
Phase 2
Conditions
Lung Cancer
Interventions
chemotherapy
Concurrent chemoradiation therapy
Concurrent chemoradiation therapy
Countries
South Korea
Protocol Section
Identification Module
NCT ID
NCT00452803
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NCCCTS-06-164
Secondary IDs
Not provided
Brief Title
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)
Official Title
A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer
Acronym
Not provided
Organization
National Cancer Center, KoreaOTHER_GOV
Status Module
Record Verification Date
Jul 2010
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2006
Primary Completion Date
Dec 2011Estimated
Completion Date
Dec 2012Estimated
First Submitted Date
Mar 27, 2007
First Submission Date that Met QC Criteria
Mar 27, 2007
First Posted Date
Mar 28, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 9, 2010
Last Update Posted Date
Jul 12, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Center, KoreaOTHER_GOV
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.
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 (50 mg/m2)on day 1, 8, 15, 22 & 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).
Postoperative Consolidation Chemotherapy:
Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles
The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence
Secondary Outcomes
Measure
Description
Time Frame
To estimate the overall survival
from the date of randomization to the date of death
To assess the pathologic complete response rate and the complete resection rate
After surgery
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.