Laparoscopic Chemotherapy for Abdominal Cancer
(Charlie-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks better ways to treat Peritoneal Carcinomatosis (PC), a cancer that spreads in the abdomen and often causes pain and eating problems. Researchers are comparing two methods of delivering chemotherapy directly into the abdomen: HIPEC (Heated Intra-Peritoneal Chemotherapy), which uses heated chemo during surgery, and PIPAC (Pressurized Intra-Peritoneal Aerosolized Chemotherapy), which uses a pressurized spray in a less invasive procedure. The goal is to determine which method is safer, more tolerable, and more effective. Ideal participants are those diagnosed with PC, who have undergone at least three months of standard chemotherapy, and are not eligible for major surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in PC treatment.
Will I have to stop taking my current medications?
The trial requires that you stop any systemic therapy (treatment affecting the whole body) at least 14 days before joining the study. If you're on any investigational drugs, you must stop them 30 days before enrolling.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have examined the safety of Heated Intra-Peritoneal Chemotherapy (HIPEC). One study found that HIPEC, which uses heated chemotherapy during surgery, is generally well-tolerated. Another study reported good survival rates with HIPEC, suggesting it could be promising for some patients, though specific details about side effects were not provided.
For Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), research shows it is also feasible and safe. One review noted side effects in about 54% of patients, with serious side effects in around 8%. This indicates that while side effects are common, serious issues are less frequent.
Both treatments deliver chemotherapy directly into the abdomen but use different methods. Overall, studies have found both HIPEC and PIPAC to be relatively safe, though side effects can occur. Discuss any concerns with a doctor, who can provide more personalized information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about laparoscopic chemotherapy for abdominal cancer because it offers innovative delivery methods. Heated intra-peritoneal chemotherapy (HIPEC) uses warm chemotherapy directly in the abdomen during surgery, which can enhance the drug's effectiveness against cancer cells. Meanwhile, pressurized intraperitoneal aerosol chemotherapy (PIPAC) delivers the drug in a fine mist, allowing better penetration into the tumor tissue. These methods stand out because they target cancer more directly than traditional systemic chemotherapy, potentially leading to fewer side effects and improved outcomes.
What evidence suggests that this trial's treatments could be effective for Peritoneal Carcinomatosis?
Research has shown that HIPEC, a treatment in this trial, circulates heated chemotherapy in the abdomen and can significantly extend the life of patients with peritoneal carcinomatosis (PC). Studies have found that using HIPEC with surgery can increase average survival time to about 27.7 months, demonstrating its effectiveness in managing PC.
Similarly, PIPAC, another treatment option in this trial, delivers chemotherapy as a pressurized spray and has also shown promising results. Patients receiving PIPAC have seen their average survival time increase from about 4.7 months to between 15 and 16 months. Both treatments in this trial have the potential to improve outcomes for those dealing with PC, though they work in different ways.26789Who Is on the Research Team?
Patrick Wagner, MD
Principal Investigator
Allegheny Health Network
Are You a Good Fit for This Trial?
This trial is for patients with cancer that has spread to the lining of their abdomen, such as stomach or pancreatic cancer. Participants should have a condition called Peritoneal Carcinomatosis and be suitable for intra-peritoneal chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three rounds of chemotherapy administered by either HIPEC or PIPAC, each about six weeks apart, during a laparoscopic procedure
Assessment
Participants undergo a laparoscopy to assess the treatment's effect and check for any side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment, with quality-of-life surveys completed at the start and after each treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aerosolized intra-peritoneal chemotherapy
- Heated intra-peritoneal chemotherapy
Trial Overview
The study compares two methods of delivering chemotherapy directly into the abdomen: HIPEC (heated chemo during surgery) and PIPAC (chemo as an aerosol during laparoscopy). It aims to determine which method is safer and more effective.
How Is the Trial Designed?
2
Treatment groups
Active Control
Laparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures.
Conventional administration of pressurized/aerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Patrick Wagner, MD, FACS
Lead Sponsor
Citations
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC ...
Specifically, the median survival increased from 4.7 to 10.5 months in patients receiving a single PIPAC session to 15–16 months in those who ...
2.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/11070/pressurized_intraperitoneal_aerosol_chemotherapy.20.aspxPressurized intraperitoneal aerosol chemotherapy in...
The median overall survival was 15.13 months. Early results indicated that PIPAC may improve survival in patients with platinum-resistant ROC ...
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC ...
Peritoneal carcinomatosis (PC) is a miserable disease with poor treatment outcome. Intraperitoneal administration of anticancer drugs enables an extremely ...
Review Article Outcomes of intraperitoneal chemotherapy ...
Median overall survival determined was 16.4 months (95%CI, 14.4–18.4). Meta-analysis of data from eight studies comparing combined intraperitoneal and systemic ...
Safety and efficacy of pressurized intraperitoneal ...
Conclusions: PIPAC with oxaliplatin is safe and feasible in a highly chemotherapy refractory cohort of appendiceal and colorectal carcinomatosis ...
a systematic review and Bayesian network meta-analysis
Moreover, 14% of GC patients present with peritoneal metastasis at diagnosis, leading to a median survival of 4-12 months and a 5-year survival ...
Efficacy and Safety of Intraoperative Hyperthermic ...
This phase 3 randomized clinical trial assesses locoregional control rates after hyperthermic intraperitoneal chemotherapy with mitomycin C
Evaluation of the feasibility, safety, and preliminary ...
The purpose of this study is to explore the feasibility and safety of using hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced ...
Prophylactic hyperthermic intraperitoneal chemotherapy ...
The results showed that the 1-, 3- and 5-year overall survival rate was significantly favorable to HIPEC (OR 5.10, 2.07, 1.96 respectively).
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