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
- 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).
- 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
- Stage IIIb or IV.