264 Participants Needed

PIPAC and Surgery for Stomach Cancer

(EPICURE Trial)

Recruiting at 4 trial locations
JS
MG
Overseen ByMartin Graversen, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Odense University Hospital
Must be taking: Neoadjuvant chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of this treatment for stomach cancer?

Research shows that cisplatin, when used in combination with other drugs like doxorubicin, has been effective in increasing the resection rates (surgical removal of cancer) for stomach cancer. Additionally, studies have found that combinations including cisplatin and doxorubicin can be more effective than some other standard treatments for advanced gastric cancer.12345

Is the treatment with Cisplatin and Doxorubicin generally safe for humans?

Cisplatin can cause kidney damage, hearing loss, and blood-related issues like anemia and low white blood cell counts. Doxorubicin is not specifically mentioned in the provided research, but it is known to have its own side effects, including heart-related issues. It's important to discuss these risks with your doctor.678910

How does PIPAC differ from other treatments for stomach cancer?

PIPAC (pressurized intraperitoneal aerosol chemotherapy) is unique because it delivers chemotherapy directly into the abdominal cavity as a pressurized aerosol, which can improve the local availability of the drugs compared to traditional methods. This approach is particularly useful for treating peritoneal metastases, where cancer has spread to the lining of the abdomen, and may offer an option for patients who are not candidates for more aggressive surgeries.1112131415

Research Team

MB

Michael Bau Mortensen, DMSci, PhD

Principal Investigator

University of Southern Denmark (sdu.dk)

Eligibility Criteria

This trial is for adults aged 18-80 with high-risk gastric cancer who can undergo minimally invasive surgery and are in good physical condition (ECOG 0-1). They must not have had allergic reactions to the chemotherapy drugs being tested, nor should they have severe heart, liver, or kidney problems. Women of childbearing age need a negative pregnancy test and must use birth control.

Inclusion Criteria

Able and willing to provide written informed consent and to comply with the clinical study protocol
I am fully active or can carry out light work.
My cancer can be of any grade.
See 10 more

Exclusion Criteria

I am allergic to cisplatin, doxorubicin, or similar drugs.
My kidney function is reduced, with a GFR less than 40 ml/min.
I have severe heart problems that limit my daily activities.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial PIPAC Treatment

Participants undergo minimally invasive D2 gastrectomy followed by pressurized intraperitoneal chemotherapy (PIPAC) with cisplatin and doxorubicin

Immediate post-surgery
1 visit (in-person)

Second PIPAC Treatment

The PIPAC procedure is repeated 6-8 weeks postoperatively before the start of adjuvant systemic chemotherapy

6-8 weeks after initial treatment
1 visit (in-person)

Follow-up

Participants are monitored for peritoneal disease-free survival and other outcomes with at least 12 months follow-up

12 months
Regular follow-up visits (in-person and/or virtual)

Treatment Details

Interventions

  • Cisplatin
  • Doxorubicin
Trial OverviewThe study tests if PIPAC therapy after minimally invasive stomach cancer surgery improves disease-free survival at one year compared to standard treatment. Patients will receive PIPAC immediately after surgery and again after 6-8 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pressurized intraperitoneal chemotherapy (PIPAC)Experimental Treatment2 Interventions
In the intervention arm, conventional pressurized intraperitoneal chemotherapy (PIPAC) with cisplatin (10.5 mg/m2 body surface in 150ml saline) and doxorubicin (2.1 mg/m2 body surface in 50ml saline) is performed through Medical Device Regulation (MDR) class IIb the CE-certified nebuliser by certified PIPAC surgeons directly after the completion of the minimally invasive gastric resection and reconstruction using the remaining relevant ports. Chemotherapy is administered through a CE-certified nebulizer according to the manufacturer's manual and followed by 30 minutes of simple diffusion. The carbondioxide is evacuated through a closed system, and the abdominal wall is closed according to local surgical standards. The same procedure is repeated, incorporating the same compounds and dose regimens six to eight weeks postoperatively and before the start of the adjuvant part of the perioperative systemic chemotherapy.
Group II: StandardActive Control1 Intervention
In the control arm, patients will undergo minimally invasive D2 gastrectomy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Odense University Hospital

Lead Sponsor

Trials
808
Recruited
1,272,000+

Karolinska University Hospital

Collaborator

Trials
509
Recruited
1,319,000+

Findings from Research

The study evaluated the safety of a triple combination therapy of Paclitaxel (PTX), Cisplatin (CDDP), and 5-fluorouracil (5-FU) in 12 patients with unresectable or recurrent gastric cancer, finding it to be a safe treatment option despite some cases of hematological and non-hematological toxicities.
While there were instances of grade 3 or higher toxicities, including leukopenia and neutropenia, no infections occurred, and the maximum tolerated dose of 5-FU was determined to be 400 mg, indicating that the combination therapy can be administered with manageable side effects.
Phase I study of paclitaxel, cisplatin and 5-fluorouracil combination chemotherapy for unresectable / recurrent gastric cancer.Kato, J., Nagahara, A., Iijima, K., et al.[2015]
In a study of 762 patients undergoing cisplatin chemotherapy, 21.7% experienced nephrotoxicity, with significant risk factors including high-dose cisplatin, cardiac disease, and hypertension.
Magnesium supplementation and diuretic use were found to reduce the risk of cisplatin nephrotoxicity, suggesting they could be effective preventive measures for at-risk patients.
Risk Factors for Cisplatin-Induced Nephrotoxicity: A Multicenter Retrospective Study.Miyoshi, T., Uoi, M., Omura, F., et al.[2021]
In a Phase I study involving 40 patients with urologic and gynecologic cancers, cis-diamminedichloroplatinum(II) (CIS-DDP) was found to have manageable side effects, primarily nausea, vomiting, and anorexia, which resolved quickly after stopping the treatment.
The study indicated low levels of hematopoietic and renal toxicities, with no reported cases of hearing disturbances or tinnitus, suggesting a favorable safety profile for CIS-DDP at doses of 50 mg/m2 for single administration and 20 mg/m2/day for five consecutive days.
[Phase I study of a new antineoplastic agent, cis-diamminedichloroplatinum (II)].[2013]

References

Phase I study of paclitaxel, cisplatin and 5-fluorouracil combination chemotherapy for unresectable / recurrent gastric cancer. [2015]
The combination of cisplatin, doxorubicin, and mitomycin (PAM) compared with the FAM regimen in treating advanced gastric carcinoma. A phase II randomized trial of the Italian Oncology Group for Clinical Research. [2013]
Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial. [2018]
Phase II study of 5-fluorouracil, pirarubicin and low-dose consecutive administration of cisplatin for advanced and recurrent gastric cancer. [2019]
Cisplatin therapy for adenocarcinoma of the stomach. [2018]
Clinical and pharmacokinetic evaluation of satraplatin. [2014]
cis-Platinum in gynecologic cancer. III. Toxicity. [2019]
[Cisplatin-induced nephrotoxic side effects of cytostatic chemotherapy of testicular tumors]. [2013]
Risk Factors for Cisplatin-Induced Nephrotoxicity: A Multicenter Retrospective Study. [2021]
[Phase I study of a new antineoplastic agent, cis-diamminedichloroplatinum (II)]. [2013]
Feasibility and Safety of Taxane-PIPAC in Patients with Peritoneal Malignancies-a Retrospective Bi-institutional Study. [2023]
Exploring the Use of Pegylated Liposomal Doxorubicin (Caelyx®) as Pressurized Intraperitoneal Aerosol Chemotherapy. [2020]
Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
PIPAC for the Treatment of Gynecologic and Gastrointestinal Peritoneal Metastases: Technical and Logistic Considerations of a Phase 1 Trial. [2022]
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) of peritoneal metastasis from gastric cancer: a descriptive cohort study. [2020]