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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00490659
Date of registration: 21/06/2007
Primary sponsor: Eli Lilly and Company
Public title: Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes
Scientific title: 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
Date of first enrolment: September 2003
Target sample size: 13
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00490659
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Poland
Contacts
Name:   Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address: 
Telephone:
Email:
Affiliation:  Eli Lilly and Company
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Non-Small Cell Lung Cancer
Intervention(s)
Drug: cisplatin
Drug: gemcitabine
Procedure: chemoradiotherapy
Procedure: radical surgery
Primary Outcome(s)
2-year overall survival
Secondary Outcome(s)
Clinical and pathological response rate to neoadjuvant chemotherapy
Disease free survival
Toxicity assessment
Assessment of feasibility of two treatment orders
Secondary ID(s)
8191
B9E-MC-S339
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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