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

Lung Cancer Clinical Trial

Official title:

Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003159
• Other study ID #: CDR0000065952
• Secondary ID: MRC-LU22EORTC-08
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: August 1997
• Est. completion date: June 2007

Study information

• Verified date: May 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• docetaxel

• gemcitabine hydrochloride

• ifosfamide

• mitomycin C

• paclitaxel

• vinblastine sulfate

• vinorelbine tartrate

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Medical Research Council Clinical Trials Unit	London	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council	European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

United Kingdom, 

References & 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 ca — View Citation

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

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-751

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival			No
Secondary	Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter			No
Secondary	Clinical and post-surgery pathological staging at pre-randomization			No
Secondary	Resectability rates			No
Secondary	Extent of surgery			No
Secondary	Time to and site of relapse			No
Secondary	Tumor response to chemotherapy			No
Secondary	Adverse effects of chemotherapy			Yes