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

December 3, 2013 updated by: Medical Research Council

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, NW1 2DA
        • Medical Research Council Clinical Trials Unit
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Adrian Hodson, Medical Research Council
  • Ian E. Smith, MD, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065952
  • MRC-LU22
  • EORTC-08012
  • EU-97016
  • ISRCTN25582437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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