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Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00003159   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
August 1997
 
Survival [ Designated as safety issue: No ]
Survival
Complete list of historical versions of study NCT00003159 on ClinicalTrials.gov Archive Site
  • Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter [ Designated as safety issue: No ]
  • Clinical and post-surgery pathological staging at pre-randomization [ Designated as safety issue: No ]
  • Resectability rates [ Designated as safety issue: No ]
  • Extent of surgery [ Designated as safety issue: No ]
  • Time to and site of relapse [ Designated as safety issue: No ]
  • Tumor response to chemotherapy [ Designated as safety issue: No ]
  • Adverse effects of chemotherapy [ Designated as safety issue: Yes ]
  • 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
 
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-Small Cell Lung Cancer
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage

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.

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.

Phase III
Interventional
Treatment, Randomized, Active Control
Lung Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
  • Drug: ifosfamide
  • Drug: mitomycin C
  • Drug: paclitaxel
  • Drug: vinblastine
  • Drug: vinorelbine ditartrate
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 
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. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
600
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00003159
 
CDR0000065952, MRC-LU22, EORTC-08012, EU-97016, ISRCTN25582437
Medical Research Council
European Organization for Research and Treatment of Cancer
Investigator: Adrian Hodson Medical Research Council
Investigator: Ian E. Smith, MD Royal Marsden - London
National Cancer Institute (NCI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP