Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	MRC-LU22 EORTC-08012, EU-97016, ISRCTN25582437, NCT00003159

Objectives

Primary

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

Secondary

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

Entry Criteria

Disease Characteristics:

• Histologically proven non-small cell lung cancer
  • Resectable disease
  • Previously untreated disease



• No evidence of distant metastases

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

Patient Characteristics:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

Outcomes

Survival

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
Tumor response to chemotherapy
Adverse effects of chemotherapy

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.

Gilligan D, Nicolson M, Smith I, et al.: 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 369 (9577): 1929-37, 2007.[PUBMED Abstract]

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.

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Adrian Hodson, Study coordinator		Ph: 44-20-7670-4735

European Organization for Research and Treatment of Cancer

Ian Smith, MD, Study coordinator		Ph: 44-20-7808-2751 Email: ian.smith@rmh.nhs.uk

Registry Information
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
Trial Start Date		1997-08-01
Registered in ClinicalTrials.gov		NCT00003159
Date Submitted to PDQ		1997-12-11
Information Last Verified		2005-05-27