Peritoneal (Metastatic) CancerPhase 2Charlie-2NCT07282834
Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
A Phase 2 study testing Heated intra-peritoneal chemotherapy and Aerosolized intra-peritoneal chemotherapy in people with Peritoneal (Metastatic) Cancer and Peritoneal Carcinomatosis, run by Patrick Wagner, MD, FACS at 1 site in United States.
Trial summary
This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal (Metastatic) Cancer, Peritoneal Carcinomatosis, Abdominal Cancer
- What is being tested?
- Heated intra-peritoneal chemotherapy and Aerosolized intra-peritoneal chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to Nov 2040
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
- Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- Must be able to read and understand English and consent for themselves
Who cannot join
- Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- AST/SGOT > 2.5 times the upper limit of normal ALT/SGPT > 2.5 times the upper limit of normal Total bilirubin > 2.5 times the upper limit of normal Hemoglobin < 7 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 50,000/mm3
- Any investigational drug use within 30 days prior to enrollment.
- Systemic therapy within 14 days prior to randomization
- Allergy or medical contra-indication to chemotherapy utilized in this study
Show all 9Show fewer
- Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
- Pregnant or lactating females.
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny Health Network West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Patrick Wagner, MD, 412-359-3731, patrick.wagner@ahn.org
AHN Clinical Trial Contact Clinical Trial Contact, 412-359-3731, clinicaltrials@ahn.org
About this study
Official title: Randomized Phase II Trial of Heated Vs. Pressurized/Aerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis
This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy).
The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.
Read the detailed description
Mitomycin C is the chemotherapy that is being administered but it is not being evaluated in the study. Mitomycin C is an FDA-approved antineoplastic antibiotic, meaning it's a type of chemotherapy drug used to treat cancer. It works by interfering with DNA synthesis, which is essential for cell growth and division. By disrupting DNA, mitomycin C can prevent cancer cells from multiplying and spreading.
The study will enroll up to 200 patients who will be randomly assigned (like the flip of a coin) to receive either HIPEC or PIPAC. Participants will be active on the study for 120-180 days.
During the study, patients will undergo standard diagnostic laparoscopies (a minimally invasive surgical procedure) to assess their eligibility for surgery to remove as much cancer as possible. Before treatment begins, small tissue samples (biopsies) will be taken for analysis in the pathology department. A small portion of this tissue will be saved by the researchers to study the effects of treatment on tumors. Patients will then receive three rounds of chemotherapy administered by either HIPEC or PIPAC, each about six weeks apart, and each during a laparoscopic procedure. Tumor tissue biopsies will be collected at the time of each treatment for analysis in the pathology department, and a small portion of each biopsy will again be saved by the researchers for laboratory work to study the effects of the treatment on tumors.
Finally, patients will have another laparoscopy to assess the treatment's effect and check for any side effects. Although patients will be followed for up to 5 years, no study-specific follow-up visits are required. Participants undergoing this type of treatment also complete quality-of-life surveys at the start of the study, and after each IP chemotherapy treatment, that asks about general health, well-being and ability to do daily activities. Patient responses to these surveys are collected for research purposes.
HIPEC and PIPAC chemotherapy, are already standard ways to treat PC. This means there's no extra risk to study participants. However, as with any treatment, there are some potential risks, such as infection inside the abdomen or injury to organs during the procedure to deliver the chemotherapy. These risks are small and would be the same whether the participant were in the study or receiving these treatments as part of their normal care.
- Conditions
- Peritoneal (Metastatic) Cancer, Peritoneal Carcinomatosis, Abdominal Cancer, Abdominal Cancer Patients
- Being tested
- Heated intra-peritoneal chemotherapy, Aerosolized intra-peritoneal chemotherapy
- Keywords
- intraperitoneal, peritoneal cavity, mitomycin-C, PIPAC, HIPEC, Heated Intra-Peritoneal Chemotherapy, Pressurized Intraperitoneal Aerosol Chemotherapy, intra-abdominal, cytoreduction
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated intra-peritoneal chemotherapyProcedure or surgery
Also called HIPEC
Mitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.
Aerosolized intra-peritoneal chemotherapyProcedure or surgery
Also called PIPAC
PIPAC will be performed with mitomycin C, 12.5mg/m2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.
| Study group | Role | What they receive |
|---|---|---|
| Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy | Active comparator | Laparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures. Receives: Procedure: Heated intra-peritoneal chemotherapy |
| Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy | Active comparator | Conventional administration of pressurized/aerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC) Receives: Procedure: Aerosolized intra-peritoneal chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Frequency of drug-related adverse events following HIPEC as assessed by CTCAE v5
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Frequency of surgical complications following HIPEC
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Severity of drug-related adverse events following HIPEC as assessed by CTCAE v5
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Severity of surgical complications following HIPEC as assessed by using Clavien-Dindo scale
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events
Frequency of drug-related adverse events following PIPAC as assessed by CTCAE v5
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events
Severity of drug-related adverse events following PIPAC as assessed by CTCAE v5
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications
Frequency of surgical complications following PIPAC
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications
Severity of surgical complications as assessed following PIPAC by using Clavien-Dindo scale
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
The relative tolerability of HIPEC as determined by length of hospital stay
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
The relative tolerability of PIPAC as determined by length of hospital stay
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
The relative tolerability of HIPEC as determined by usage of pain medication in opioid equivalents prior to discharge
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
The relative tolerability of PIPAC as determined by usage of pain medication in opioid equivalents prior to discharge
Measured: 150 days from Day #1 visit
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
The relative tolerability of HIPEC as determined by patient-reported outcomes using the Short Form-20 instrument
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
The relative tolerability of PIPAC as determined by patient-reported outcomes using the Short Form-20 instrument
Measured: 150 days from Day #1 visit
Secondary outcomes (10)
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Serological indicators of tumor response following HIPEC using serum levels of CEA, CA19-9 or CA-125 as applicable in individual patients
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Serological indicators of tumor response following PIPAC using serum levels of CEA, CA19-9 or CA-125 as applicable in individual patients
Measured: 150 days from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Radiographic indicators of tumor response following HIPECusing RECIST criteria, when available.
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Radiographic indicators of tumor response following PIPAC using RECIST criteria, when available
Measured: 150 days from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Proportion of patients achieving complete cytoreduction following HIPEC using the Completeness of Cytoreduction score
Measured: 5.5 years from Day #1 visit
Pressurized Intraperitoneal Aerosol (PIPAC) Efficacy
Proportion of patients achieving complete cytoreduction following PIPAC using the Completeness of Cytoreduction score
Measured: 5.5 years from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Total cost of care following PIPAC using hospital financial records to determine the total direct cost in US dollars
Measured: 5.5 years from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Total cost of care following PIPAC using hospital financial records to determine the total direct cost in US dollars
Measured: 5.5 years from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Biomarkers analysis of treatment response using tissue biopsy
Measured: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Biomarkers analysis of treatment response using tissue biopsy
Measured: 150 days from Day #1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start5 Jan 2026
- Primary completionDec 2035 (estimated)
- Study completionNov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal (Metastatic) 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Wagner, MD, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Wagner, MD, FACS, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Patrick Wagner, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282834
- Sponsor's protocol ID
- 2025-177
- Acronym
- Charlie-2
- Status last verified
- Feb 2026
- First submitted
- 30 Oct 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Heated Vs. Pressurized/Aerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT07282834
- Acronym / sponsor ID
- Charlie-2 / 2025-177
- Conditions
- Peritoneal (Metastatic) Cancer, Peritoneal Carcinomatosis, Abdominal Cancer, Abdominal Cancer Patients
- Keywords
- intraperitoneal, peritoneal cavity, mitomycin-C, PIPAC, HIPEC, Heated Intra-Peritoneal Chemotherapy, Pressurized Intraperitoneal Aerosol Chemotherapy, intra-abdominal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Patrick Wagner, MD, FACSUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Nov 2040 (estimated)
- First posted
- 15 Dec 2025 (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 research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy).
The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.
Detailed description
Mitomycin C is the chemotherapy that is being administered but it is not being evaluated in the study. Mitomycin C is an FDA-approved antineoplastic antibiotic, meaning it's a type of chemotherapy drug used to treat cancer. It works by interfering with DNA synthesis, which is essential for cell growth and division. By disrupting DNA, mitomycin C can prevent cancer cells from multiplying and spreading.
The study will enroll up to 200 patients who will be randomly assigned (like the flip of a coin) to receive either HIPEC or PIPAC. Participants will be active on the study for 120-180 days.
During the study, patients will undergo standard diagnostic laparoscopies (a minimally invasive surgical procedure) to assess their eligibility for surgery to remove as much cancer as possible. Before treatment begins, small tissue samples (biopsies) will be taken for analysis in the pathology department. A small portion of this tissue will be saved by the researchers to study the effects of treatment on tumors. Patients will then receive three rounds of chemotherapy administered by either HIPEC or PIPAC, each about six weeks apart, and each during a laparoscopic procedure. Tumor tissue biopsies will be collected at the time of each treatment for analysis in the pathology department, and a small portion of each biopsy will again be saved by the researchers for laboratory work to study the effects of the treatment on tumors.
Finally, patients will have another laparoscopy to assess the treatment's effect and check for any side effects. Although patients will be followed for up to 5 years, no study-specific follow-up visits are required. Participants undergoing this type of treatment also complete quality-of-life surveys at the start of the study, and after each IP chemotherapy treatment, that asks about general health, well-being and ability to do daily activities. Patient responses to these surveys are collected for research purposes.
HIPEC and PIPAC chemotherapy, are already standard ways to treat PC. This means there's no extra risk to study participants. However, as with any treatment, there are some potential risks, such as infection inside the abdomen or injury to organs during the procedure to deliver the chemotherapy. These risks are small and would be the same whether the participant were in the study or receiving these treatments as part of their normal care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy | Active comparator | Procedure: Heated intra-peritoneal chemotherapyLaparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures. |
| Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy | Active comparator | Procedure: Aerosolized intra-peritoneal chemotherapyConventional administration of pressurized/aerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
- Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
Key exclusion criteria (9 listed)
- Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- AST/SGOT > 2.5 times the upper limit of normal ALT/SGPT > 2.5 times the upper limit of normal Total bilirubin > 2.5 times the upper limit of normal Hemoglobin < 7 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 50,000/mm3
- Any investigational drug use within 30 days prior to enrollment.
- Systemic therapy within 14 days prior to randomization
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 |
|---|---|---|
| Heated intra-peritoneal chemotherapyAlso: HIPECMitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed. | Procedure or surgery | Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy |
| Aerosolized intra-peritoneal chemotherapyAlso: PIPACPIPAC will be performed with mitomycin C, 12.5mg/m2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed. | Procedure or surgery | Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy |
Primary outcome
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Time frame: 150 days from Day #1 visit
Frequency of drug-related adverse events following HIPEC as assessed by CTCAE v5
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Time frame: 150 days from Day #1 visit
Frequency of surgical complications following HIPEC
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events
Time frame: 150 days from Day #1 visit
Severity of drug-related adverse events following HIPEC as assessed by CTCAE v5
Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications
Time frame: 150 days from Day #1 visit
Severity of surgical complications following HIPEC as assessed by using Clavien-Dindo scale
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events
Time frame: 150 days from Day #1 visit
Frequency of drug-related adverse events following PIPAC as assessed by CTCAE v5
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events
Time frame: 150 days from Day #1 visit
Severity of drug-related adverse events following PIPAC as assessed by CTCAE v5
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications
Time frame: 150 days from Day #1 visit
Frequency of surgical complications following PIPAC
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications
Time frame: 150 days from Day #1 visit
Severity of surgical complications as assessed following PIPAC by using Clavien-Dindo scale
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of HIPEC as determined by length of hospital stay
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of PIPAC as determined by length of hospital stay
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of HIPEC as determined by usage of pain medication in opioid equivalents prior to discharge
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of PIPAC as determined by usage of pain medication in opioid equivalents prior to discharge
Heated intra-peritoneal chemotherapy (HIPEC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of HIPEC as determined by patient-reported outcomes using the Short Form-20 instrument
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability
Time frame: 150 days from Day #1 visit
The relative tolerability of PIPAC as determined by patient-reported outcomes using the Short Form-20 instrument
10 secondary outcomes
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Time frame: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Time frame: 150 days from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Time frame: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Time frame: 150 days from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Time frame: 5.5 years from Day #1 visit
Pressurized Intraperitoneal Aerosol (PIPAC) Efficacy
Time frame: 5.5 years from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Time frame: 5.5 years from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Time frame: 5.5 years from Day #1 visit
Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy
Time frame: 150 days from Day #1 visit
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy
Time frame: 150 days from Day #1 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
Patrick Wagner, MD principal investigator
Allegheny Health Network
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 Heated intra-peritoneal chemotherapy and Aerosolized intra-peritoneal chemotherapy in people with Peritoneal (Metastatic) Cancer and Peritoneal Carcinomatosis, run by Patrick Wagner, MD, FACS 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Wagner, MD (412-359-3731, patrick.wagner@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events (time frame: 150 days from Day #1 visit). The study lists 14 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 27 Feb 2026.