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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed no age specified LCSG-772

Objectives

I.  Compare combination chemotherapy (CAP-I) versus combination immunotherapy 
with BCG/isoniazid/levamisole for their ability to prolong the survival and 
increase the cure rate of patients with completely resected Stages II and III 
large cell adenocarcinoma of the lung.
II.  Compare the two treatment regimens for their effects on patterns of 
disease recurrence and metastases.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients with 
apparently totally resected Stage II or III large cell, undifferentiated or 
adenocarcinoma of the lung, with adequate bilirubin, creatinine and 
hematologic levels.  Amended in Addendum 2, April 1980 to exclude any prior 
thoracic radiotherapy, chemotherapy, or immunotherapy within the past 5 years 
and prior history of any other cancer unless there has been a 5-year 
disease-free interval.  Patients must be staged at surgery, must not have any 
distant metastases, other neoplasms, recently active tuberculosis or active 
cardiac disease (defined in Addendum 2, April 1980, as a myocardial infarction 
within 4 months or any ventricular arrhythmia requiring medication).

Expected Enrollment

As of August 1982, 118 patients had been randomized; accrual is expected to 
proceed at about 20 patients/year for an additional six months.  Protocol 
closed May 1984.

Outline

Randomized study.
Arm I:  Immunotherapy.  BCG-Tice, BCG, NSC-B116327; Isoniazid, INH, NSC-9659; 
Levamisole, LEV, NSC-177023.  For fever:  Aspirin, NSC-27223; plus Benadryl, 
NSC-33299.
Arm II:  3-Drug Combination Chemotherapy.  CAP-I:  CTX, NSC-26271; Adriamycin, 
ADR, NSC-123127; cis-Platinum, CACP, NSC-119875.

Holmes EC: Surgical adjuvant therapy for stage II and stage III adenocarcinoma and large cell undifferentiated carcinoma. Chest 106 (6 Suppl): 293S-296S, 1994.[PUBMED Abstract]

Holmes EC, Gail M: Surgical adjuvant therapy for stage II and stage III adenocarcinoma and large-cell undifferentiated carcinoma. J Clin Oncol 4 (5): 710-5, 1986.[PUBMED Abstract]

Holmes EC, Hill LD, Gail M: A randomized comparison of the effects of adjuvant therapy on resected stages II and III non-small cell carcinoma of the lung. The Lung Cancel Study Group. Ann Surg 202 (3): 335-41, 1985.[PUBMED Abstract]

Should subcarinal lymph nodes be routinely examined in patients with non-small cell lung cancer? The Lung Cancer Study Group. J Thorac Cardiovasc Surg 95 (5): 883-7, 1988.[PUBMED Abstract]

Figlin RA, Piantadosi S, Feld R: Intracranial recurrence of carcinoma after complete surgical resection of stage I, II, and III non-small-cell lung cancer. N Engl J Med 318 (20): 1300-5, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Lung Cancer Study Group

E. Carmack Holmes, MD, Protocol chair		Ph: 310-206-2105; 888-798-0719 Email: cholmes@mednet.ucla.edu