Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)

NCT07282834 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-177
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; cytoreduction

Outcome Measures

Primary Outcomes (14)

• Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events

  Frequency of drug-related adverse events following HIPEC as assessed by CTCAE v5

  150 days from Day #1 visit

• Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications

  Frequency of surgical complications following HIPEC

  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

  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

  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

  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

  150 days from Day #1 visit

• Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications

  Frequency of surgical complications following PIPAC

  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

  150 days from Day #1 visit

• Heated intra-peritoneal chemotherapy (HIPEC) Tolerability

  The relative tolerability of HIPEC as determined by length of hospital stay

  150 days from Day #1 visit

• Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability

  The relative tolerability of PIPAC as determined by length of hospital stay

  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

  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

  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

  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

  150 days from Day #1 visit

Secondary Outcomes (10)

• Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy

  150 days from Day #1 visit

• Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy

  150 days from Day #1 visit

• Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy

  150 days from Day #1 visit

• Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Efficacy

  150 days from Day #1 visit

• Heated Intra-Peritoneal Chemotherapy (HIPEC) Efficacy

  5.5 years from Day #1 visit

Study Arms (2)

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.

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)

Procedure: Aerosolized intra-peritoneal chemotherapy

Interventions

Heated intra-peritoneal chemotherapy PROCEDURE

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.

Also known as: HIPEC

Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy

Aerosolized intra-peritoneal chemotherapy PROCEDURE

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.

Also known as: PIPAC

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Patrick Wagner, MD, FACS: lead

Study Sites (1)

Allegheny Health Network West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Patrick Wagner, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Wagner, MD

CONTACT

412-359-3731; patrick.wagner@ahn.org

AHN Clinical Trial Contact Clinical Trial Contact

CONTACT

412-359-3731; clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treating investigator, participant and care provider will know which procedural arm the participant is assigned to after the enrollment visit has concluded and informed consent has been signed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, AHNCI Division of Complex General Surgical Oncology

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: December 15, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): November 1, 2040
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)