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

This study has been completed.
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: May 2005

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.

Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: ifosfamide
Drug: mitomycin C
Drug: paclitaxel
Drug: vinblastine sulfate
Drug: vinorelbine tartrate
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: August 1997
Study Completion Date: June 2007
Detailed Description:



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


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven non-small cell lung cancer

    • Resectable disease
    • Previously untreated disease
  • No evidence of distant metastases



  • Any age

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


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


  • Not specified


  • Not specified


  • Considered fit for chemotherapy and surgical resection
  • No other disease or prior malignancy that would preclude study treatment
  • No active infection


Biologic therapy:

  • No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
  • No concurrent immunotherapy


  • Not specified

Endocrine therapy:

  • No concurrent hormonal agents, except corticosteroids


  • Not specified


  • Not specified


  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003159

United Kingdom
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medical Research Council
European Organisation for Research and Treatment of Cancer - EORTC
OverallOfficial: Adrian Hodson Medical Research Council
OverallOfficial: Ian E. Smith, MD Royal Marsden NHS Foundation Trust
  More Information

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. Identifier: NCT00003159     History of Changes
Other Study ID Numbers: CDR0000065952
Study First Received: November 1, 1999
Last Updated: December 3, 2013

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antibiotics, Antineoplastic
Nucleic Acid Synthesis Inhibitors processed this record on April 26, 2017