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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490659

Enrollment

Registered

2007-06-25

Start date

2003-09-30

Completion date

2004-12-31

Last updated

2007-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief 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.

Interventions

DRUGgemcitabine

DRUGcisplatin

PROCEDUREradical surgery

PROCEDUREchemoradiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
2-year overall survival	—

Secondary

Measure	Time frame
Toxicity assessment	—
Assessment of feasibility of two treatment orders	—
Clinical and pathological response rate to neoadjuvant chemotherapy	—
Disease free survival	—

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026