Clinical trial · Interventional
Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to recurrence
Secondary outcomes (6)
- measure
- Overall survival
- measure
- Toxicity
- measure
- Safety, in terms of frequency, severity, and relationship of adverse events, as assessed by NCI CTCAE v3.0
- measure
- Complete resection rate
- measure
- Quality of life as assessed by EORTC QLQ-C30 and EORTC QLQ-LC13 at baseline and periodically for 5 years
- measure
- Patient population most at risk for disease recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Squamous cell or nonsquamous cell histology * Stage IB or II disease * Tumor amenable to curative surgical resection PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * Medical fitness must be adequate for radical NSCLC surgery * WBC ≥ 4,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin normal * ALT and AST ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * No second primary malignancy * No active uncontrolled infection * No concurrent serious disorder that would compromise patient safety or tolerance of study therapy * No significant neurological or mental disorder * No myocardial infarction within the past 6 months * No symptomatic heart disease, including any of the following: * Unstable angina * Congestive heart failure * Uncontrolled arrhythmia PRIOR CONCURRENT THERAPY: * No prior chemotherapy or anticancer therapy * No prior surgery for NSCLC * No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier) * No major surgery (other than biopsy) within the past 2 weeks * No other concurrent anticancer therapy * No other concurrent investigational agents
References
Publications (0)
Data not yet available