Lung Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug and combining chemotherapy with
radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of
radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin
and etoposide in treating patients with stage II or stage III non-small cell lung cancer
that cannot be removed surgically.
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
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