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Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on November 1, 1999.   Last Updated on February 26, 2011   History of Changes
Sponsor: Medical Research Council
Collaborator: European Organization for Research and Treatment of Cancer - EORTC
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003159
  Purpose

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 III

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:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Mitomycin Cisplatin Paclitaxel Carboplatin Vinorelbine Gemcitabine Docetaxel Gemcitabine hydrochloride Vinorelbine tartrate Vinblastine sulfate Vinblastine Mitomycins Ifosfamide
U.S. FDA Resources

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

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: August 1997
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003159

Locations
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 Organization for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Adrian Hodson Medical Research Council
Investigator: Ian E. Smith, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.
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.

ClinicalTrials.gov Identifier: NCT00003159     History of Changes
Other Study ID Numbers: CDR0000065952, MRC-LU22, EORTC-08012, EU-97016, ISRCTN25582437
Study First Received: November 1, 1999
Last Updated: February 26, 2011
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitomycins
Mitomycin
Isophosphamide mustard
Gemcitabine
Vinorelbine
 Docetaxel
Cisplatin
Ifosfamide
Vinblastine
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012



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