Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer

NCT00003159 | Completed Phase 3

• 5 other identifiers: CDR0000065952MRC-LU22EORTC-08012EU-97016ISRCTN25582437
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage 0 non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival

Secondary Outcomes (7)

• Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter

• Clinical and post-surgery pathological staging at pre-randomization

• Resectability rates

• Extent of surgery

• Time to and site of relapse

Interventions

carboplatin DRUG

cisplatin DRUG

docetaxel DRUG

gemcitabine hydrochloride DRUG

ifosfamide DRUG

mitomycin C DRUG

paclitaxel DRUG

vinblastine sulfate DRUG

vinorelbine tartrate DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (2)

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (3)

• Gilligan 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 RESULT

• Hopwood 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.

  RESULT

• Nicolson 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin; Docetaxel; Gemcitabine; Ifosfamide; Mitomycin; Paclitaxel; Vinblastine; Vinorelbine; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics

Study Officials

• Adrian Hodson

  Medical Research Council

• Ian E. Smith, MD

  Royal Marsden NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: August 1, 1997
• Study Completion: June 1, 2007
• Last Updated: December 4, 2013

Record last verified: 2005-05

Locations

GB (2)