Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer
- Determine time to progression from surgery in patients who have undergone cytoreductive
surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or
adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant
- Estimate progression-free survival probability of patients treated with this regimen.
- Obtain toxicity data for patients receiving long-term oral thalidomide therapy.
OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every
28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
60 months after treatment
Perry Shen, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|