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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: cisplatin
* Procedure: radical surgery
* Procedure: chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: cisplatin|nan|
|Procedure: radical surgery|nan|
|Procedure: chemoradiotherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity assessment |  |  | 
| Assessment of feasibility of two treatment orders |  |  | 
| Clinical and pathological response rate to neoadjuvant chemotherapy |  |  | 
| Disease free survival |  |  |