Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Combination Chemotherapy Followed by Surgery or Radiation Therapy Compared With Radiation Therapy Alone in Treating Patients With Non-small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	any age		MRC-LU20 EU-95041

Objectives

I.  Compare the survival of patients with previously untreated, unresectable 
stage IIIA (T3 N1 M0 or T1-3 N2 M0) non-small cell lung cancer treated with 
standard fractionated thoracic radiotherapy vs. neoadjuvant chemotherapy with 
MVP (mitomycin/vinblastine/cisplatin) or MIC (mitomycin/ifosfamide/cisplatin) 
followed, as feasible, by surgery or radiotherapy.

II.  Evaluate the adverse effects of these treatment regimens.

III.  Assess the quality of life, i.e., physical, functional and psychological 
status, and the impact of health on social functioning and activities of daily 
living in these patients.

Entry Criteria

Disease Characteristics:

Histopathologically proven non-small cell lung cancer
  Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node
  biopsy, sputum cytology, or bronchial brushing or fine needle aspirate
  cytology

Previously untreated, unresectable stage IIIA disease (T3 N1 M0 or T1-3 N2 M0)
with potential to become resectable following neoadjuvant treatment

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  Any age

Performance status:
  WHO 0-2

Hematopoietic:
  Blood counts normal

Hepatic:
  Not specified

Renal:
  Creatinine clearance greater than 50 mL/min

Other:
  No prior or concurrent malignancy that interferes with protocol treatments
     or comparisons
  No other condition that contraindicates either treatment
  Able to undergo a pneumonectomy (according to usual local criteria)
  Willing and able to complete SF-36 questionnaire
     Completion of first questionnaire required prior to entry

Expected Enrollment

350 patients will be entered over 3 years.

Outline

Randomized study.  The following acronyms are used:
  CDDP     Cisplatin, NSC-119875
  IFF      Ifosfamide, NSC-109724
  Mesna    Mercaptoethane sulfonate, NSC-113891
  MIC      MITO/IFF/CDDP
  MITO     Mitomycin, NSC-26980
  MVP      MITO/VBL/CDDP
  VBL      Vinblastine, NSC-49842

Arm I:  Standard Fractionated Radiotherapy.  Thoracic irradiation (equipment 
not specified).

Arm II:  3-Drug Combination Chemotherapy followed by Surgery or Radiotherapy 
as feasible.  MVP or MIC; followed by resection or thoracic irradiation as 
feasible.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

David J. Girling, MD, Protocol chair		Ph: 44-20-7670-4734