Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes

Non-Small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490659
• Other study ID #: 8191
• Secondary ID: B9E-MC-S339
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2007
• Last updated: June 21, 2007
• Start date: September 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• gemcitabine

• cisplatin

Procedure:
• radical surgery

• chemoradiotherapy

Locations

Country	Name	City	State
Poland	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival
Secondary	Toxicity assessment
Secondary	Assessment of feasibility of two treatment orders
Secondary	Clinical and pathological response rate to neoadjuvant chemotherapy
Secondary	Disease free survival

External Links

•   Lilly Clinical Trial Registry