Clinical trial · Interventional
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| mitomycin C | Drug | Mitomycin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| paclitaxel |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival
Secondary outcomes (7)
- measure
- Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter
- measure
- Clinical and post-surgery pathological staging at pre-randomization
- measure
- Resectability rates
- measure
- Extent of surgery
- measure
- Time to and site of relapse
- measure
- Tumor response to chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven non-small cell lung cancer * Resectable disease * Previously untreated disease * No evidence of distant metastases PATIENT CHARACTERISTICS: Age: * Any age Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Other: * Considered fit for chemotherapy and surgical resection * No other disease or prior malignancy that would preclude study treatment * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis) * No concurrent immunotherapy Chemotherapy: * Not specified Endocrine therapy: * No concurrent hormonal agents, except corticosteroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent anticancer therapy
References
Publications (3)
- RESULTGilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4. PMID 17544497
- RESULTHopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007.
- RESULTNicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007.