Stomach CancerNCT03604653
Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers
An observational study of Stomach Cancer and Colorectal Cancer, run by Holy Name Medical Center, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Colorectal Cancer, Appendiceal Cancer
- What is being tested?
- HIPEC, Mitomycin c and CDDP 50
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age >18
- Diagnosis at the time of resection or on frozen section of:
- recurrent or primary stomach, colorectal or appendiceal cancer with regional spread that is confined to the peritoneal cavity
- primary peritoneal cancer
- ovarian cancer stage IC or higher
- uterine or cervical cancer stage IIA or higher with recurrence confined to the peritoneum
Show all 14Show fewer
- fallopian tube cancer stage III or recurrence confined to the peritoneum ECOG performance status of 0,1, or 2
- Lab values:
- absolute neutrophil count >1500
- platelets >100,000
- creatinine less than or equal to 2.0mg/dL
- bilirubin less than or equal to 1.5 times the upper limit of normal
- SGOT and alkaline phosphatase less than or equal to 2.5 times the upper limit of normal
- patients of childbearing age must have a negative serum pregnancy test and be using an effective form of contraception
Who cannot join
- Extra-peritoneal disease or unresectable disease
- Any known sensitivity to the chemotherapeutic agents used in the study
- Significant medical comorbidities that would prevent the patient from being able to complete the protocol (at discretion of investigator)
- Patients with gynecological malignancy who desire future fertility
- An informed consent cannot be obtained from the patient or power of attorney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Primary Peritoneal Cancers and Secondary Peritoneal Cancers From Stomach, Colorectal, Appendiceal, and/or Gynecological Origins
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stomach Cancer, Colorectal Cancer, Appendiceal Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer
- Being tested
- HIPEC, Mitomycin c, CDDP 50, CDDP 75, Doxorubicin
- Keywords
- HIPEC, Stomach cancer, colorectal cancer, appendiceal cancer, ovarian cancer, uterine cancer, cervical cancer, fallopian tube cancer, primary peritoneal carcinoma, intraperitoneal chemotherapy
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Appendiceal Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECDevice
Also called Chemo bath
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Mitomycin cDrug
Also called MMC
MMC 30mg@ T0, 10mg@T45 min
CDDP 50Drug
Also called Cisplatin
50mg/m2@T0
CDDP 75Drug
Also called Cisplatin
75mg/m2@T0
DoxorubicinDrug
Also called DXR
15mg/m2@T0
| Study group | Role | What they receive |
|---|---|---|
| Stomach | Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0 Receives: Device: HIPEC; Drug: Mitomycin c; Drug: CDDP 50 | |
| Colorectal, Appendiceal, Pseudomyxoma Peritonei | Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes Receives: Device: HIPEC; Drug: Mitomycin c | |
| Primary Peritoneal | Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0 Receives: Device: HIPEC; Drug: CDDP 50; Drug: Doxorubicin | |
| Ovarian, Cervical, Uterine, Fallopian Tube | Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 75mg/m2 at time 0 Receives: Device: HIPEC; Drug: CDDP 75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from HIPEC treatment to death
Measured: up to 10 years
Disease-free Survival
Time from HIPEC treatment to either recurrence or relapse of cancer, or death
Measured: up to 10 years
Secondary outcomes (4)
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
Measured: 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
Measured: Up to 10 years
Tumor Markers
Cancer-specific tumor markers will be measured 6 months post operatively and then yearly.
Measured: 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
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start15 May 2018
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holy Name Medical Center, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604653
- Sponsor's protocol ID
- holynameHIPEC1
- Status last verified
- Aug 2022
- First submitted
- 12 Jul 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Primary Peritoneal Cancers and Secondary Peritoneal Cancers From Stomach, Colorectal, Appendiceal, and/or Gynecological Origins
- ClinicalTrials.gov ID
- NCT03604653
- Acronym / sponsor ID
- holynameHIPEC1
- Conditions
- Stomach Cancer, Colorectal Cancer, Appendiceal Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer
- Keywords
- HIPEC, Stomach cancer, colorectal cancer, appendiceal cancer, ovarian cancer, uterine cancer, cervical cancer, fallopian tube cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Holy Name Medical Center, Inc.University, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stomach | – | Device: HIPEC, Drug: Mitomycin c, Drug: CDDP 50Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0 |
| Colorectal, Appendiceal, Pseudomyxoma Peritonei | – | Device: HIPEC, Drug: Mitomycin cHeated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes |
| Primary Peritoneal | – | Device: HIPEC, Drug: CDDP 50, Drug: DoxorubicinHeated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0 |
| Ovarian, Cervical, Uterine, Fallopian Tube | – | Device: HIPEC, Drug: CDDP 75Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 75mg/m2 at time 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (14 listed)
- Age >18
- recurrent or primary stomach, colorectal or appendiceal cancer with regional spread that is confined to the peritoneal cavity
- primary peritoneal cancer
- ovarian cancer stage IC or higher
- uterine or cervical cancer stage IIA or higher with recurrence confined to the peritoneum
Key exclusion criteria (5 listed)
- Extra-peritoneal disease or unresectable disease
- Any known sensitivity to the chemotherapeutic agents used in the study
- Significant medical comorbidities that would prevent the patient from being able to complete the protocol (at discretion of investigator)
- Patients with gynecological malignancy who desire future fertility
- An informed consent cannot be obtained from the patient or power of attorney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPECAlso: Chemo bathHeated chemotherapy is pumped into the abdomen and circulated for 90 minutes | Device | Colorectal, Appendiceal, Pseudomyxoma Peritonei, Ovarian, Cervical, Uterine, Fallopian Tube, Primary Peritoneal, Stomach |
| Mitomycin cAlso: MMCMMC 30mg@ T0, 10mg@T45 min | Drug | Colorectal, Appendiceal, Pseudomyxoma Peritonei, Stomach |
| CDDP 50Also: Cisplatin50mg/m2@T0 | Drug | Primary Peritoneal, Stomach |
| CDDP 75Also: Cisplatin75mg/m2@T0 | Drug | Ovarian, Cervical, Uterine, Fallopian Tube |
| DoxorubicinAlso: DXR15mg/m2@T0 | Drug | Primary Peritoneal |
Primary outcome
Overall Survival
Time frame: up to 10 years
Time from HIPEC treatment to death
Disease-free Survival
Time frame: up to 10 years
Time from HIPEC treatment to either recurrence or relapse of cancer, or death
4 secondary outcomes
Complications
Time frame: 90 Days
Treatment related quality of life changes as measured by the WHO QOL-BREF questionnaire
Time frame: Up to 10 years
Tumor Markers
Time frame: up to 10 years
Toxicity as measured by treatment related adverse events according to the NCI CTCAE v 4.0
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Cancer and Colorectal Cancer, run by Holy Name Medical Center, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.