A Phase II Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (-With Weekly Low-Dose Gemcitabine) in the Treatment of Nodes Positive NSCLC Patients

Eli Lilly and Company1 site in 1 country13 target enrollmentSeptember 2003

ConditionsNon-Small Cell Lung Cancer

Drugsgemcitabine cisplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Enrollment: 13
Locations: 1
Primary Endpoint: 2-year overall survival
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test feasibility, toxicity and efficacy of two different adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with positive lymph nodes.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

December 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For patients entering Arm B is also allowed to confirm histopathological diagnosis of NSCLC intraoperatively during this trial.
•Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained from intraoperative or post-surgery pathology report.
•Tumor amenable to curative surgical resection.
•Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria.
•Pathological evaluation is performed after mediastinoscopy or after surgery
•No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).

Exclusion Criteria

•Treatment within the last 30 days with any investigational drug.
•Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
•Serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator's discretion.
•Presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
•Stage IIIb or IV.