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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: chemoradiotherapy; Drug: gemcitabine; Procedure: radical surgery; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490659

8191

B9E-MC-S339

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)