A Phase 2 interventional study of PIPAC in Peritoneum; Carcinomatosis, Peritoneal Neoplasms and Peritoneal Metastases, sponsored by Michael Bau Mortensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by Michael Bau Mortensen · Phase 2, Interventional, and Treatment
Among 14 studies testing cisplatin in Peritoneal Neoplasms — 4 open to participants now, 6 under way, none of them phase 3. Cisplatin · Peritoneal Neoplasms.
Among the 14 studies testing cisplatin in Peritoneal Neoplasms, this one has the largest enrollment, is one of 3 that started in 2016, is one of 8 in phase 2, and was the 9th registered.
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's enrollment of 143 is above the median of 46 across 202 interventional studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →4 of the 14 studies testing cisplatin in Peritoneal Neoplasms are open now, in 1 country. Each count lists the studies.
Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →
Of the 49 Peritoneal Neoplasms studies recruiting now, 35 (71%) set no upper age limit and 8 (16%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 3 started in 2016.
Median enrollment 27 across the 14 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
None of the 14 has an industry lead sponsor. The 10 most frequent:
Michael Bau Mortensen is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Michael Bau Mortensen has 3 studies filed under Peritoneal Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing cisplatin in Peritoneal Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03127774Columbia UniversitySurgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma | 2026-12 |
Among the 14 studies testing cisplatin in Peritoneal Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This is a study, where the efficacy of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) against peritoneal metastases will be evaluated. Furthermore, this study will focus on the best evaluation method, where both Quality of Life questionnaires, repeated histology, cytology and MRI will be used.
Patients with peritoneal metastases (PM) will be reviewed by the interdisciplinary tumor board and included based on predefined in- and exclusion criteria. Eligible candidates with primary colorectal or appendiceal cancers will be treated with intraperitoneal oxaliplatin delivered by the PIPAC procedure, while patients with other primary cancers will be treated with a combination of cisplatin and doxorubicin. Three PIPAC treatments will be scheduled in intervals of 4-6 weeks (6-7 if combined with systemic chemotherapy). MRI and QoL questionnaires will be performed at baseline and after three PIPAC treatments. If the patients respond to the PIPAC treatment, further courses of PIPAC can be planned at the tumour board meeting.
In brief, PIPAC is performed during a standard laparoscopy using two access ports, where the magnitude of PM is evaluated using the Peritoneal Carcinosis Index and the Dutch 7 regions count. Afterwards, the peritoneum is biopsied at different regions and peritoneal lavage fluid is sent for cytology. Then, chemotherapy is aerosolised within the abdomen, and after 30 minutes, the aerosol has been absorbed by the peritoneum, and the patient is closed according to departmental guidelines. The patients are expectedly discharged within 24 hours, and will after each PIPAC treatment be screened for adverse events using the CTCAE and Dindo-Clavien classification.
Amendment 23-03-2020:
Title Evaluation of the Peritoneal Regression Grading Score in biopsies from clips marked peritoneal metastases compared to biopsies from the element with most malignant features during repeated Pressurized IntraPeritoneal Aerosol Chemotherapy
Background Patients with peritoneal metastases (PM) may be treated with protocolled Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) at Odense PIPAC Center by inclusion in the prospective PIPAC-OPC2 study. The response evaluation is based on repeated biopsies from clips marked PM elements retrieved during each PIPAC procedure. Histological regression is categorized by the Peritoneal Regression Grading Score (PRGS). While the PRGS is internationally validated and accepted, there is a lack of consensus regarding the biopsy strategy during subsequent PIPAC procedures. As part of the PIPAC-OPC2 protocol, we define the element with most malignant features in each of the four abdominal quadrants during the first PIPAC procedure. We clips mark these elements to be able to take biopsies from the same area during subsequent procedures, thus reducing sampling error. At other centres, the biopsies are taken from those elements that are most suspicious of malignancy at visual inspection during each PIPAC.
The question is whether the histological regression in repeated biopsies from clips marked elements is influenced by fibrosis from the clips or dominated by scar tissue induced by the biopsy per se. Moreover, it is possible that PMs may progress in unmarked areas, in spite of regression in the marked areas. Hypothetically, this could lead to false positive regression, thus overestimating the histological response to PIPAC.
Objective To investigate if the histologically assessed response to PIPAC is dependent on the biopsy strategy: Biopsies taken from those areas that are most suspicious of malignancy at visual inspection compared to re-biopsies of the same, clips marked PM elements during the second PIPAC procedure.
Number of patients Data from 131 consecutive patients included in the PIPAC-OPC1 or PIPAC-OPC2 studies show that 67% had more than one PIPAC procedure. The mean PRGS was reduced by 0.38 points (SD 0.65) from PIPAC 1 to PIPAC 2, based on re-biopsies from clips marked elements.
With an alpha of 0.05 and a power of 0.80, 25 patients are needed to test the null hypothesis of no difference between the two biopsy strategies. Patients are their own control.
Methods The present study is an amendment to the PIPAC-OPC2 study. To date, 101/137 patient have been included. With an expected study termination of no more than 30% of the patients before PIPAC 2, this amendment is feasible within the framework of the PIPAC-OPC2 study.
A clips marked element is defined as the area covered within two times the length of the opened jaws of a biopsy forceps. An external surgical oncologist with vast experience of staging cancer patients will define the PM element with most malignant features before retrieval of biopsies during the second PIPAC procedure. Accordingly, biopsies will then be taken from the clips marked elements and the defined element with most malignant features (potentially same element). The pathologist will be blinded during the analyses of biopsies from the second PIPAC procedure.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
Peritoneal metastases (PM) from colorectal or appendiceal cancer will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. Peritoneal metastases (PM) from other GI or gynecologic cancers will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using cisplatin 7.5 mg/m2 in 150 ml saline combined with doxorubicin 1.5 mg/m2 in 50 ml saline. PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 200 PSI and a flow rate of 0.5 ml/min. There is no upper number of allowed PIPAC treatments, but they will be planned in series of 3 with 4-6 weeks interval (6-7 weeks if combined with systemic chemotherapy).
Drug: PIPAC
Also known as: Cisplatin, Doxorubicin, Oxaliplatin
Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures.
Objective Tumor response will be evaluated by the Peritoneal Regression Grading Score based on repeated peritoneal biopsies during each PIPAC procedure.
Time frame: 4 years
Number of patients with improved Quality of Life (QoL)
Based on EORTC QLQC30 questionnaire at baseline and after 3 PIPAC treatments
Time frame: 4 years
Number of patients where MRI is accurate in describing PM distribution and progressive/regressive disease
Based on MRI of the abdomen at baseline and after 3 PIPAC treatments, it will be evaluated, whether MRI can detect PM and whether MRI can be used to evaluate progression/regression during PIPAC treatment. Comparative gold standard is laparoscopy including biopsies
Time frame: 4 years
Plan to share: No — Publications and presentations will be based on patient data, but the database is not open to other researchers.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cisplatin
Michael Bau Mortensen