Some colorectal cancer patients will have their cancer spread into the tissue within their abdomen or to the surfaces of abdominal organs. This condition, called peritoneal carcinomatosis, can be treated successfully if it is recognized early. Unfortunately, it is often not seen on routine scanning and not diagnosed when surgical treatment is possible.
A clinical trial at the NIH Clinical Center in Bethesda will see if a second surgery to look for peritoneal carcinomatosis in high-risk patients can find the disease earlier, treat it appropriately, and improve survival.
Eligible patients for the trial will have already had surgery that removed all visible tumor and are considered to have no evidence of disease (NED). However, their cancer will have some high-risk features that makes it more likely that they might develop peritoneal carcinomatosis in the future.
The trial is not intended for patients who already have peritoneal carcinomatosis.
Between 11 and 14 months after their original surgery patients at high-risk for peritoneal cancer recurrence but with no current evidence of disease will be randomly assigned to have their follow-up care provided by:
- Standard-of-care surveillance with blood tests, physical exams, and CT scanning, or
- Mandatory second-look surgery (MSLS).
If peritoneal carcinomatosis is found on second-look surgery, all visible tumor will be removed (cytoreduction) and heated intraperitoneal chemotherapy (HIPEC) infused into the abdomen at the end of surgery.
High-risk features than increase risk for PC and make patients eligible for the trial include colorectal cancer that
- Perforated into the peritoneal cavity.
- Included minimal peritoneal carcinomatosis (PC) which was completely surgically removed at the time of initial operation.
- Was a T4 lesion that required surgery to remove additional organs along with the colon or rectal tumor.
- Was associated with ovarian metastases.
- Presented as an emergency with tumors associated with obstruction and/or bleeding.
Patients who had limited extra abdominal metastases the time of diagnosis may be eligible if the lesions were completely removed surgically and the patient remains NED.
More information about the trial is available from the principal investigator:
- Itzhak Avital, M.D.
- Principal Investigator
- Phone: 301-402-0083
- Fax: 301-496-0734
To enroll in the trial or make a referral:
- Melissa Walker, R.N., B.S.N.
- Research Nurse
- Phone: 301-451-6940
- Fax: 301-594-5356
Note: Contact Dr. Avital or Ms. Walker for more information about the trial. Do not call Fight Colorectal Cancer.
Treatment at the NIH Clinical Center in Bethesda, Maryland
There is no charge for medical care received at the National Institutes of Health Clinical Center. Patients do have to pay for transportation for initial screening visits, but transportation and housing are provided for clinical trial participants. You will need to maintain your medical coverage for any care you receive outside the NIH Clinical Center.
In an abstract presented at the 2011 Digestive Disease Week, surgeons Ashraf Haddad and Jesus Esquivel from St. Agnes Hospital in Baltimore reviewed staging for 28 patients in their peritoneal dissemination cases whose peritoneal carcinomatosis developed after their original stage II or III colorectal cancer diagnosis. They found that stage IIIc patients had peritoneal tumors develop more rapidly than average, and in 5 out of 6 cases disease was too advanced for surgery and HIPEC chemotherapy. The doctors concluded,
It appears from these data that patients with stage IIIC colorectal cancer develop carcinomatosis at a faster rate and in a more virulent form when compared to other stages. Trials at preventing carcinomatosis in this group of patients are needed.