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

NCT ID: NCT00003159

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-08-31
• Study Completion Date: 2007-06-30

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.

Detailed Description

OBJECTIVES:

Primary

• Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.

Secondary

• Compare the quality of life of patients treated with these regimens.
• Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
• Compare resectability rates in patients treated with these regimens.
• Compare time to and site of relapse in patients treated with these regimens.
• Determine response in patients treated with preoperative chemotherapy.
• Determine the adverse effects of preoperative chemotherapy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
• Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:

• Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
• Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
• Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
• Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
• Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
• Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

mitomycin C

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

vinblastine sulfate

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Adrian Hodson

Role:

Medical Research Council

Ian E. Smith, MD

Role:

Royal Marsden NHS Foundation Trust

Locations

Medical Research Council Clinical Trials Unit

London, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 17544497 (View on PubMed)

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.

Reference Type: 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.

Reference Type: RESULT

Other Identifiers

MRC-LU22

Identifier Type: -

Identifier Source: secondary_id

EORTC-08012

Identifier Type: -

Identifier Source: secondary_id

EU-97016

Identifier Type: -

Identifier Source: secondary_id

ISRCTN25582437

Identifier Type: -

Identifier Source: secondary_id

CDR0000065952

Identifier Type: -

Identifier Source: org_study_id