Peritoneum; CarcinomatosisPhase 2PIPAC-OPC2NCT03287375
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -
A Phase 2 study testing PIPAC in people with Peritoneum; Carcinomatosis and Peritoneal Neoplasms, run by Michael Bau Mortensen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneum; Carcinomatosis, Peritoneal Neoplasms, Peritoneal Metastases
- What is being tested?
- PIPAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2016to 1 Oct 2022
- Phase
- Phase 2
- 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
Who may be able to join
- Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).
- Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.
- Radiological, histological or cytological evidence of PC.
- No indication for CRS and HIPEC (according to National Guidelines).
- Performance status 0-1.
- No more than a single extra-peritoneal metastasis.
Show all 9Show fewer
- Age > 18 years.
- Females must be post-menopausal
- Written informed consent must be obtained according to the local Ethics Committee requirements.
Who cannot join
- Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube).
- Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
- A history of allergic reaction to platinum containing compounds or doxorubicin.
- Renal impairment, defined as GFR < 40 ml/min, (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as NYHA class > 2.
- Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
- Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x109/l.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial
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.
Read the detailed description
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.
- Conditions
- Peritoneum; Carcinomatosis, Peritoneal Neoplasms, Peritoneal Metastases, Chemotherapy Effect, Chemotherapeutic Toxicity, Quality of Life
- Being tested
- PIPAC
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACDrug
Also called Cisplatin, Doxorubicin, Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| PIPAC | Experimental | 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). Receives: Drug: PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (2)
Number of patients with improved Quality of Life (QoL)
Based on EORTC QLQC30 questionnaire at baseline and after 3 PIPAC treatments
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Dec 2016
- Primary completion1 Feb 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peritoneum; CarcinomatosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohorte study
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Bau Mortensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Bau Mortensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287375
- Sponsor's protocol ID
- PIPAC-OPC2
- Acronym
- PIPAC-OPC2
- Status last verified
- Oct 2022
- First submitted
- 2 Sep 2017
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publications and presentations will be based on patient data, but the database is not open to other researchers.
Publications
Solass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.
PubMed 24006094Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.
PubMed 24275155Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.
PubMed 23765417Graversen M, Lundell L, Fristrup C, Pfeiffer P, Mortensen MB. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) as an outpatient procedure. Pleura Peritoneum. 2018 Nov 27;3(4):20180128. doi: 10.1515/pp-2018-0128. eCollection 2018 Dec 1.
PubMed 30911669Graversen M, Detlefsen S, Asmussen J, Mahdi B, Fristrup C, Pfeiffer P, Mortensen MB. Treatment of peritoneal carcinomatosis with Pressurized IntraPeritoneal Aerosol Chemotherapy - PIPAC-OPC2. Pleura Peritoneum. 2018 Jun 9;3(2):20180108. doi: 10.1515/pp-2018-0108. eCollection 2018 Jun 1.
PubMed 30911656
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial
- ClinicalTrials.gov ID
- NCT03287375
- Acronym / sponsor ID
- PIPAC-OPC2 / PIPAC-OPC2
- Conditions
- Peritoneum; Carcinomatosis, Peritoneal Neoplasms, Peritoneal Metastases, Chemotherapy Effect, Chemotherapeutic Toxicity, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Michael Bau MortensenUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 19 Sep 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohorte study
| Arm | Type | Receives |
|---|---|---|
| PIPAC | Experimental | Drug: PIPACPeritoneal 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).
- Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.
- Radiological, histological or cytological evidence of PC.
- No indication for CRS and HIPEC (according to National Guidelines).
- Performance status 0-1.
Key exclusion criteria (7 listed)
- Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube).
- Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
- A history of allergic reaction to platinum containing compounds or doxorubicin.
- Renal impairment, defined as GFR < 40 ml/min, (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as NYHA class > 2.
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 |
|---|---|---|
| PIPACAlso: Cisplatin, Doxorubicin, Oxaliplatin | Drug | PIPAC |
Primary outcome
Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures.
Time frame: 4 years
Objective Tumor response will be evaluated by the Peritoneal Regression Grading Score based on repeated peritoneal biopsies during each PIPAC procedure.
2 secondary outcomes
Number of patients with improved Quality of Life (QoL)
Time frame: 4 years
Number of patients where MRI is accurate in describing PM distribution and progressive/regressive disease
Time frame: 4 years
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 7 Oct 2022.
- Background: PubMed 24006094Solass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.
- Background: PubMed 24275155Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.
- Background: PubMed 23765417Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.
- Derived from this study: PubMed 30911669Graversen M, Lundell L, Fristrup C, Pfeiffer P, Mortensen MB. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) as an outpatient procedure. Pleura Peritoneum. 2018 Nov 27;3(4):20180128. doi: 10.1515/pp-2018-0128. eCollection 2018 Dec 1.
- Derived from this study: PubMed 30911656Graversen M, Detlefsen S, Asmussen J, Mahdi B, Fristrup C, Pfeiffer P, Mortensen MB. Treatment of peritoneal carcinomatosis with Pressurized IntraPeritoneal Aerosol Chemotherapy - PIPAC-OPC2. Pleura Peritoneum. 2018 Jun 9;3(2):20180108. doi: 10.1515/pp-2018-0108. eCollection 2018 Jun 1.
- Individual participant dataSharing planned: No. Publications and presentations will be based on patient data, but the database is not open to other researchers.
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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?
A Phase 2 study testing PIPAC in people with Peritoneum; Carcinomatosis and Peritoneal Neoplasms, run by Michael Bau Mortensen at 1 site in Denmark.
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 9 inclusion and 7 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 7 Oct 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287375, which also lists 5 linked publications.
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 7 Oct 2022.