Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases
- Peritoneal carcinomatosis (PC) from colorectal cancer (CRC) treated with chemotherapy
alone results in median survival of 5 to 13 months.
.-Approximately, 55% of high risk patients (Patients presenting with synchronous PC,
ovarian metastases perforated primary, and emergency presentation with bleeding or
obstructing lesions) will develop PC.
- Early PC is undetectable by conventional imaging.
- Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for
early PC from CRC resulted in median survival of 48-63 months and 5 year survival of 51
- This study is a prospective randomized trial designed to answer the question whether
mandatory second look surgery (MSLS) with CRS and HIPEC will prolong overall survival
when compared to the standard of care.
- To compare the overall survival of patients at high risk for developing PC from CRC who
undergo M SLS + HIPEC and CRS (if applicable) vs. similar patients who receive standard of
- To determine recurrence-free survival in both arms.
- To investigate selection criteria for patient who might benefit from a strategy of MSLS
with CRS + HIPEC.
- Patients who have undergone curative resection f or CRC who are at high risk for
- Patients who shown no evidence of disease at the time of enrollment
- Patients with ECOG less than or equal to 0-2 and suitable candidates for laparotomy,
HIPEC and CRS.
- High risk CRC patients for developing PC who underwent curative surgery and
subsequently received standard of care and remained NED for 12 months after primary
surgery will be randomized into MSLS/CRS/HIPEC or continuing standard of care.
- HIPEC will be done using Oxaliplatin/5-FU/Leucovorin.
- Up to 100 patients will be enrolled to allow for 35 evaluable patients in each arm;
accrual is expected to last 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care.
Follow-up will occur every 3 months for two years, every six months for three ye
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|