A Three-Arm Phase III Study of Concomitant Versus Sequential Chemotherapy and Thoracic Radiotherapy for Patients With Locally Advanced Inoperable Non-small Cell Lung Cancer
OBJECTIVES: I. Compare the survival rate of patients with locally advanced, unresectable
non-small cell lung cancer randomized to concomitant vinblastine/cisplatin (VBL/CDDP) and
thoracic radiotherapy versus sequential VBL/CDDP and once-daily thoracic radiotherapy. II.
Compare the survival rate of such patients randomized to 2 courses of concomitant
etoposide/cisplatin and hyperfractionated thoracic radiotherapy versus sequential VBL/CDDP
and once-daily thoracic radiotherapy. III. Assess the frequency of treatment-related
esophageal and hematologic toxicity/morbidity in patients on concomitant versus sequential
chemoradiation treatment arms.
OUTLINE: Randomized study. The following acronyms are used: CDDP Cisplatin, NSC-119875 VBL
Vinblastine, NSC-49842 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy
Followed by Radiotherapy. CDDP/VBL; followed by thoracic irradiation using photons of at
least 6 MV (electrons may be used to boost the supraclavicular lymph nodes). Arm II:
Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as
in Arm I; plus CDDP/VBL. Arm III: Hyperfractionated Radiotherapy plus 2-Drug Combination
Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VP-16.
PROJECTED ACCRUAL: A total of 597 patients will be entered over 3.1-4.2 years. If fewer than
6 patients/month are accrued, the feasibility of the study will be re-evaluated.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
from date of randomization to date of death or last follow-up for patients still alive
Walter J. Curran, MD
Kimmel Cancer Center (KCC)
United States: Federal Government