An observational study in Stomach Cancer, Colorectal Cancer and Appendiceal Cancer, sponsored by Holy Name Medical Center, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Holy Name Medical Center, Inc. · Observational
Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC).
To be eligible for the study, patients must be over 18 years of age, have appropriate pathology and stage with disease confined to the peritoneal cavity, have a good performance status, have laboratory values that fall within safe ranges to undergo an operation and receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned based on pathological diagnosis in accordance with current standard of care.
Surgery will be performed with the goal of removing all visible tumor that may require removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion device. This will continue for 90 minutes.
Patients will be followed for tumor response, survival, toxicity, complications, quality of life, and tumor markers. They will have regular follow up visits with the surgeon, undergo routine surveillance imagings, and receive follow up phone calls periodically.
Peritoneal carcinomatosis can be caused by primary peritoneal cancers and secondary peritoneal spread from stomach, colorectal, appendiceal, and/or gynecological cancers. Combined presentation of patients with peritoneal carcinomatosis make up about 67,000 new cancer diagnoses each year. Of these cases, about 25,000 patients are estimated to be candidates for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC); however, in 2009 only five percent of these patients received such treatment.
Alternative therapies to cytoreductive surgery and HIPEC are few. They include surgical treatments with cytoreduction alone which are palliative in nature and inadequate to manage the disease, radiation which is limited in regard to tumors disseminated throughout abdominal cavity, systemic chemotherapy which has poor penetration into the peritoneum. Intraperitoneal chemotherapy via indwelling peritoneal catheter is limited due to port infections, toxicity, and unequal distribution in the abdominal cavity.
For patients whose disease is limited to the peritoneal cavity, multi-modality treatment with cytoreductive surgery followed by intraoperative HIPEC can deliver chemotherapy directly to microscopic tumors at a higher concentration than is tolerated systemically. It causes disruption of cell membranes and induces apoptosis. Moreover when intraperitoneal chemotherapy is given at a higher temperature, it has a selective lethal effect on cancer cells secondary to improved tissue absorption. The typical side effects of systemic chemotherapy are also minimized with HIPEC.
HIPEC is given intraoperatively in one treatment setting after all visible disease has been resected (i.e., cytoreductive surgery). The goal of cytoreductive surgery is to leave behind only microscopic disease and may require removal of adjacent organs. HIPEC is then delivered via tubings with temperature probes that are placed in the intraperitoneal cavity. The skin is then temporarily closed and the tubings are connected to a intraperitoneal hyperthermia and perfusion device that delivers sterile solution with chemotherapy into the abdomen. The device heats and circulates the chemotherapy for 90 minutes. After HIPEC is completed, abdomen is reopened and copiously irrigated. Surgical reconstruction with any removed organs (such as bowel) and fascial/skin closure are the final steps.
Previous studies have shown conflicting results on survival benefit for patients with some of the aforementioned secondary peritoneal cancers who have undergone cytoreductive surgery and HIPEC. This study is an outcomes based study that seeks to look at the impact of HIPEC on overall survival and recurrence-free survival.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 10 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Holy Name Medical Center, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with primary peritoneal cancers and secondary peritoneal cancers from stomach, colorectal, appendiceal, and/or gynecological origins who are eligible by stage and pathology for surgical debulking and HIPEC, and who meet criteria to undergo an extensive operation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age >18
Diagnosis at the time of resection or on frozen section of:
Lab values:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0
Device: HIPEC · Drug: Mitomycin c · Drug: CDDP 50
Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes
Device: HIPEC · Drug: Mitomycin c
Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0
Device: HIPEC · Drug: CDDP 50 · Drug: Doxorubicin
Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 75mg/m2 at time 0
Device: HIPEC · Drug: CDDP 75
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Also known as: Chemo bath
MMC 30mg@ T0, 10mg@T45 min
Also known as: MMC
50mg/m2@T0
Also known as: Cisplatin
75mg/m2@T0
Also known as: Cisplatin
15mg/m2@T0
Also known as: DXR
Overall Survival
Time from HIPEC treatment to death
Time frame: up to 10 years
Disease-free Survival
Time from HIPEC treatment to either recurrence or relapse of cancer, or death
Time frame: up to 10 years
Complications
Patients who undergo cytoreductive surgery followed by HIPEC will be monitored to record the incidence of the following complications: fistula, leak, pulmonary embolus, deep vein thrombosis, re-operation, hematologic
Time frame: 90 Days
Treatment related quality of life changes as measured by the WHO QOL-BREF questionnaire
Treatment related quality of life changes will be measured by the WHO QOL-BREF at each follow up visit
Time frame: Up to 10 years
Tumor Markers
Cancer-specific tumor markers will be measured 6 months post operatively and then yearly.
Time frame: up to 10 years
Toxicity as measured by treatment related adverse events according to the NCI CTCAE v 4.0
Toxicity as measured by adverse events grade III-V according to NCI CTCAE v.4.0
Time frame: 90 Days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Holy Name Medical Center, Inc.