Study objectives: The purpose of this phase III
clinical trial was to test whether chemotherapy followed by radiation
therapy resulted in superior survival to either hyperfractionated
radiation or standard radiation in surgically unresectable non-small
cell lung cancer.
Design: Patients were prospectively
randomized to 2 months of cisplatin, vinblastine chemotherapy followed
by 60 Gy of radiation at 2.0 Gy per fraction or 1.2 Gy per fraction
radiation delivered twice daily to a total dose of 69.6 Gy, or 2.0 Gy
per fraction of radiation once daily to 60 Gy. Patients were enrolled
from January 1989 through January 1992, and followed for a potential
minimum period of 5 years.
Setting: This trial was an
intergroup National Cancer Institute–funded trial within the Radiation
Therapy Oncology Group, the Eastern Cooperative Oncology Group, and the
Southwest Oncology Group.
Patients: Patients with
surgically unresectable non-small cell lung cancer, clinical stage II,
IIIA, and IIIB, were required to have a Karnofsky Performance Status of≥
70 and a weight loss of < 5% for 3 months before study entry.
Four hundred ninety patients were registered on trial, of which 458
patients were eligible.
Conclusion: Overall survival
was statistically superior for the patients receiving chemotherapy and
radiation vs the other two arms of the study. The twice-daily radiation
therapy arm, although better, was not statistically superior in
survival for those patients receiving standard radiation. Median
survival for standard radiation was 11.4 months; for chemotherapy and
irradiation, 13.2 months; and for hyperfractionated irradiation, 12
months. The respective 5-year survivals were 5% for standard radiation
therapy, 8% for chemotherapy followed by radiation therapy, and 6%
for hyperfractionated irradiation.