A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
- Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when
administered with cisplatin in patients with optimally debulked stage III or IV
carcinoma of the endometrium.
OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel
IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive
cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment
with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last
course of standard chemotherapy or no later than 1 week before the start of cisplatin and
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose
(RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of
6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as assessed by GOG Common Toxicity Criteria
Aaron H. Wolfson, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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