A Phase 2 interventional study of PIPAC in Peritoneal Carcinomatosis, sponsored by Michael Bau Mortensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-12.
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 is the 6th largest by enrollment, is the only one that started in 2015, is one of 8 in phase 2, and was the 5th registered.
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's enrollment of 35 is below 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. 1 started in 2015.
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 feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal cancer.
Peritoneal carcinomatosis (PC) represents end stage disease in many types of cancer (e.g. gastric, pancreatic, liver, colo-rectal, ovarian) and the majority of patients with PC will die from their disease within 6 months. Platinum-based systemic chemotherapy (SC) may prolong survival in selected patients, but poor performance status and low response rates have led to conservative (nihilistic) treatment strategies in these patients. However, patients with PC who are in good condition, and with a remaining life expectancy of more than a few months, may still have an unmet need for additional treatment in order to be able to perform with a high quality of life for as long as possible. These patients often have tried several lines of SC with disappointing results, and alternative and more effective treatment strategies are desperately needed.
The installation of chemotherapeutic agents within the peritoneal cavity would seem a simple and effective treatment of PC - at least from a theoretical point of view. Unfortunately, the effect of intraperitoneal chemotherapy on PC is disappointing. Like with SC, the poor response rates may be explained by the poor penetration of the active chemical substances into the PC plaques. Combining cytoreductive surgery (CRS) with intraperitoneal chemotherapy has gained interest in the recent years, but this approach can only be used in highly selected patients (where CRS is possible), and the procedure carries a significant risk of complications and side effects. Thus, a minimally invasive and safe delivery of relevant chemotherapy in such concentration that may allow it to work efficiently on the PC plaques would be an ideal platform for a new treatment strategy in these patients.
Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) Temperature and pressure are important factors during absorption of fluid from the peritoneal cavity, and the use of a relative low intraperitoneal pressure (2-6 mmHg) seems to increase the inflow of intraperitoneal fluid into the abdominal wall. Studies have confirmed that higher tissue concentrations of chemotherapy may be obtained by increasing the intraperitoneal pressure. After years of extensive testing, and the development of a micro-pump for safe aerosol infusion, a German research group has designed a system that allows a laparoscopy controlled, intraperitoneal aerosol infusion of chemotherapy (doxorubicin and cisplatin). The aerosol technique ensures that the entire peritoneal surface is covered by chemotherapy, and this is relevant in patients with PC. With the micro-pump positioned through a standard trocar pointing away from the bowels, a commercially available injection pump provides the necessary pressure to induce an aerosol mist covering the peritoneal cavity. After five minutes, the chemotherapy has been delivered, and the injector is turned off. After an additional 25 minutes of simple diffusion, the intra-abdominal air saturated with chemotherapy is evacuated through a standard trocar.
Recently, a German research group published their preliminary experience with PIPAC in gastric and ovarian cancer patients with PC .
PIPAC is not available freely on the market, and the procedure is not FDA approved yet. The German research team has emphasized, that despite the very encouraging results obtained so far, the efficacy and safety of PIPAC still has to be assessed in adequate clinical trials.
Aim In a compassionate use program, the aim of this study is to implement and evaluate the PIPAC procedure at Odense University Hospital under strict observation of both patient and occupational health safety aspects. Thus, it is important to emphasize, that the primary aim of this feasibility study is a quick and safe implementation of a new combined surgical-oncologic treatment technique which uses conventional chemotherapy in a new way in desperately ill cancer patients. For technical and safety reasons this implementation needs to be fulfilled and documented before patients can be enrolled in clinical trials.
Hypothesis The investigators expect the PIPAC procedure to be feasible and safe, with a primary non-access ratio of maximum 7:35 (mainly due to adhesions). The investigators expect a CTCAE grade of no more than 3 and that the procedure is safe for both patients, surgeons and OR staff.
Method
Study design This is a feasibility study where the PIPAC procedure will be performed in 35 patients fulfilling the inclusion criteria.
Implementation of the PIPAC procedure In order to cover all safety aspects and to secure optimal treatment results, a complete manual and checklist for the entire PIPAC procedure, as well as for pre- and postoperative patient handling, has been made. Thus, every step of the procedure is carefully described and monitored, and prior to the first patient treatment, the entire PIPAC procedure will be tried in a "dummy" OR setup supervised by the German group. Although this group has documented, that the procedure is safe for both patients and health care workers, the procedure will only be performed in an OR with laminar airflow and a closed carbon dioxide (CO2) ventilation system. In addition, environmental measurements (platinum particles within the OR) and bio-monitoring (blood samples) of the OR team are scheduled from the beginning of the first PIPAC procedure.
Preliminary clinical evaluation 35 patients with PC (see inclusion criteria) will be scheduled for PIPAC. In collaboration with the German group, the local multidisciplinary team (MDT) meeting will carefully select patients suitable for the PIPAC procedure. These patients are included according to national regulations and rules on experimental cancer research. All PIPAC procedures are performed with prophylactic antibiotics and start with a classification of the extent of the PC (Peritoneal Cancer Index, PCI) followed by selected quadrant biopsies to document malignancy and for later translational research. The type and doses of chemotherapy (1/10 of systemic dose), intra-abdominal pressure, temperature and delivery time are similar to those used by the German group. After the PIPAC procedure, the patients will be observed for two days before discharge. The treatment response is monitored by CT, and by a follow-up laparoscopy procedure with PCI score and biopsies after six weeks. The PIPAC procedure will be repeated during the same evaluation laparoscopy if objective response or no progression is observed. Adverse medical events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0), and surgical related complications according to the Dindo-Clavien classification.
Intra-abdominal access and completion of the PIPAC procedure in 28 of 35 patients and discharge of the same group within 2 POD are considered a successful implementation of the PIPAC procedure.
Occupational health safety aspects For safety reasons no staff is in the OR during the PIPAC procedure. The injector is controlled by a footswitch from outside the OR room, and observation monitors related to the anesthesiology are also made visible from outside the OR. Since no personnel are inside the ventilated OR room during application of the aerosolized chemotherapy, there are three barriers between surgeons/OR staff and the chemotherapy: The closed abdominal cavity, the laminar airflow system and the OR walls. The tightness of the abdominal cavity is controlled by allowing a maximum CO2 flow of 0.1-0.2 L/min corresponding to the body resorption of CO2. After the procedure, intraabdominal air saturated with chemotherapy is evacuated through a series of filters and into a closed system. Closure of the trocar sites, removal and disposal of dressings and syringes into special chemotherapy waste bins are performed by the surgeon alone. Environmental biomonitoring and blood samples from the surgeons and OR staff are scheduled as part of the safety monitoring.
Patient safety All patients are carefully selected (see exclusion criteria) on the MDT. The establishing of pneumoperitoneum and use of trocars are based on the highest standards for laparoscopic surgery which have a high safety profile. The procedures are performed by experienced laparoscopic surgeons under the supervision of the German team. When following the safety protocol used by the German group, no mortality related to the PIPAC procedure has been observed. The risk of bowel perforation is 2 per mille, port site metastases occur in 0.6% of the procedures, and self- limiting erythema around the trocar site is found in 1.2% of the procedures (private communication, professor Marc A. Reymond).
A short period of postoperative fever and/or elevated acute phase proteins have been observed after the PIPAC procedure, but the majority of patients may be discharged the same or the following day, and the PIPAC procedure can be repeated several times.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
PIPAC with cisplatin (7.5mg/m2 in 150 ml saline) and doxorubicin (1.5mg/m2 in 50 ml saline) in patients with peritoneal metastases (PM) from any origin besides colorectal/appendiceal cancers in whom oxaliplatin (92mg/m2 in 150 ml dextrose) will be used. The aerosolised chemotherapy will be nebulized at a flow of 0.5ml/min at a maximum pressure of 200 PSI during a standard laparoscopy with an intraabdominal pressure of 12mmHg. The CO2 will be evacuated 30 minutes after administration of chemotherapy and the patient is closed similar to a standard laparoscopy.
Drug: PIPAC
Also known as: Cisplatin, Doxorubicin, Oxaliplatin
Number of Patients with Adverse Events.
No patients with adverse events above grade 3 on the CTCAE (Version 4) scale. No patients with complications above grade 2 on the Dindo-Clavien classification.
Time frame: 5 months.
Occupational health.
No detectable chemotherapy on environmental biomonitoring and blood samples from the surgeons and OR staff.
Time frame: 5 months.
Feasibility: Completion of procedure in 28:35
Completion of procedure in 28:35.
Time frame: 5 months.
This study is completed, as verified in Sep 2017. 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