Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 70 and under MRC-LU03 EU-94018

Objectives

I.  Determine quality of life, time to disease progression, and survival in 
patients with limited stage small cell lung cancer treated with radiotherapy 
alone vs. radiotherapy followed by cyclophosphamide/methotrexate/lomustine 
(CTX/MTX/CCNU).

II.  Determine quality of life, time to disease progression, and survival in 
patients with extensive stage small cell lung cancer treated with single-agent 
CTX (1.0 g/sqm q 3 weeks) vs. CTX/MTX/CCNU.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven small cell lung
carcinoma confirmed by one of the following:
  Bronchial biopsy
  Mediastinal or other lymph node biopsy
  Pleural biopsy (pleural effusions not acceptable)
  Lung biopsy (by needle, trephine, or open surgery)
  Sputum cytology (bronchial brushings not acceptable)

  Histologic review at Brompton Hospital, London, required

All small cell types (WHO classification) eligible, including:
  Fusiform
  Polygonal
  Lymphocyte-like
  Small anaplastic

Limited and extensive stage disease eligible
  Limited stage defined by clinical and radiologic evidence as:
     Disease confined to the mediastinum and soft tissue
     of the ipsilateral thorax, including ipsilateral and
     contralateral scalene and ipsilateral and
     contralateral lower cervical nodes

     Small malignant or benign pleural effusions occupying
     no more than one-third of the ipsilateral hemithorax

     Disease associated with superior vena cava
     obstruction with no other signs of spread

     Disease encompassable within the proposed
     radiotherapy field

  Extensive disease defined by clinical and radiologic exam as:
     Disease that has spread beyond the mediastinum and
     ipsilateral hemithorax, including pleural effusion
     occupying more than one-third of the hemithorax

  The following are not by themselves indicators of extensive
  disease:
     Functional endocrine or neurologic syndrome

     Bone marrow examination or isotopic scan

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior cytotoxic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  No surgery except thoracotomy (with or without biopsy)

Patient Characteristics:

Age:
  70 and under

Performance status:
  Not specified

Life expectancy:
  Survival time not compromised by advanced disease

Hematopoietic:
  No abnormalities of the blood

Hepatic:
  Not specified

Renal:
  BUN no greater than 60 mg/dl

Other:
  No serious condition that would preclude protocol therapy
  No coexisting disease that would interfere with disease
     assessment
  No other major or advanced disease
  No pregnant women

Expected Enrollment

As of April 1977, 330 patients were registered and 253 were randomized.

Outline

Randomized study.  Patients with limited stage disease are randomized to Arms 
I and II, while those with extensive stage disease are randomized to Arms III 
and IV.  The following acronyms are used:
  CCNU    Lomustine, NSC-79037
  CTX     Cyclophosphamide, NSC-26271
  MTX     Methotrexate, NSC-740

Arm I:  Radiotherapy.  Involved-field irradiation using megavoltage x-ray or 
Co60 gamma ray equipment.

Arm II:  Radiotherapy followed by 3-Drug Combination Chemotherapy.  
Radiotherapy as in Arm I; followed by CTX; MTX; CCNU.

Arm III:  Single-Agent Chemotherapy.  CTX.

Arm IV:  3-Drug Combination Chemotherapy.  CTX; MTX; CCNU.

Radiotherapy alone or with chemotherapy in the treatment of small-cell carcinoma of the lung: the results at 36 months. 2nd report to the Medical Research Council on the 2nd small-cell study. Br J Cancer 44 (5): 611-7, 1981.[PUBMED Abstract]

Radiotherapy alone or with chemotherapy in the treatment of small-cell carcinoma of the lung. Medical Research Council Lung Cancer Working Party. Br J Cancer 40 (1): 1-10, 1979.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Peter Fayers, MD, Protocol chair		Ph: 44-20-7670-4700