Lung Cancer Clinical Trial
Official title:
A Phase I/II Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination
chemotherapy in treating patients with limited-stage small cell lung cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an
accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II.
Evaluate the response rate and overall survival in these patients. III. Reduce the toxic
effects of treatment to esophagus and lungs.
OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one
of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for
4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days
during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a
week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5.
(Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18
days followed by radiation boost given in the evenings on days 19 and 20, then twice daily
for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive
radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on
days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as
the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each
radiation dose level. If one patient experiences nonhematologic dose limiting toxicity
(DLT), 5 additional patients are treated at that level. If no further DLT occurs, escalation
to the next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of
radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are
followed every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10
months.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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