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
- Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they were diagnosed, have a high risk of cancer recurrence even after surgery or other treatment.
- If additional tumors are discovered early and removed while they are still small (often before they can show up on scans), survival rates may improve. In addition, patients who receive a heated chemotherapy solution delivered directly to the abdomen often have better treatment outcomes regardless of whether additional tumors were found. Further research can help determine the usefulness of both of these treatments in improving the outcomes of patients with colorectal cancer.
- To determine whether patients who have had surgery for colorectal cancer have improved outcomes after receiving additional surgery combined with direct chemotherapy, compared with those who receive the current standard of care.
- Individuals at least 18 years of age who have had surgery for colorectal cancer within the past 14 months, who are considered to be at high risk for cancer recurrence, and whose current imaging scans show no signs of additional tumors.
- Participants will be divided into two treatment groups: a surgery group and a standard of care group.
- Participants who had surgery less than 11 months ago will be enrolled in a 3-month lead-in phase to receive standard follow-up care, including labs, scans, and physical examinations, before being randomized to a treatment group between 11 and 14 months after surgery. Participants who had surgery between 11 and 14 months ago will be randomized at the time of enrollment.
- Participants in the surgery group will have the following procedures within 2 weeks of randomization:
- Abdominal surgery where surgeons will look for and remove any tumors and take biopsies to check for cancer cells
- Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen
- In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.
- Participants in the standard of care group will have the standard follow-up schedule for high-risk colorectal cancer patients:
- Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and yearly thereafter....
Procedure: Laparotomy+ HIPEC +/- CRS
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: Follow-up will occur every 3 months for two years, every six months for three ye ] [ Designated as safety issue: No ]
- To determine recurrence-free survival in both arms. To investigate selection criteria for patients who might benefit from a strategy of MSLS with CRS + HIPEC. [ Time Frame: Follow-up will occur every 3 months for two years, every six months for three ye ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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 care.
- 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 recurrence
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095523
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|