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Alkylating agents

Heated Chemotherapy for Abdominal Cancer (TOASTIT Trial)

Phase < 1

Waitlist Available

Led By Patricio C. Gargollo, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of distant metastases at the time of enrollment

Evidence of macroscopic or microscopic intra-peritoneal seeding (separate from the primary tumor) identified at the time of exploratory surgery with or without primary tumor resection

Must not have

Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung), Known bone marrow involvement

Patients with an active infection requiring treatment or having an unexplained febrile illness (Tmax > 99.5 Fahrenheit [F]), patients with known immune deficiency disorder or known human immunodeficiency virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well doxorubicin and cisplatin work when heated and directly infused into the abdomen to treat abdominal or pelvic tumors.

Who is the study for?

This trial is for pediatric patients with certain abdominal or pelvic tumors that are resectable, refractory, or recurrent. They must have a performance score indicating they can participate in daily activities and no distant metastases. Patients should not be pregnant, breastfeeding, or have severe systemic illnesses.

What is being tested?

The study tests heated intra-peritoneal chemotherapy using doxorubicin and cisplatin during surgery to treat specific tumors. The heat may help kill more cancer cells when the chemo solution circulates in the abdomen.

What are the potential side effects?

Potential side effects include damage to organs from chemotherapy drugs (like heart problems from doxorubicin), kidney issues due to cisplatin, surgical complications, and risks associated with general anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to distant parts of my body.

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Cancer cells were found in my abdomen during surgery.

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My kidney function is good, based on recent tests.

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I can care for myself but may not be able to do active work.

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My platelet count is at least 50,000 without transfusions.

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My peritoneal cancer index is 20 or less, and surgeons believe they can remove all my tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to organs like the liver, brain, or lungs, or is in my bone marrow.

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I do not have an active infection needing treatment, a fever over 99.5°F, or HIV.

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I am not pregnant or breastfeeding.

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I've had a severe allergic reaction to chemotherapy before.

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I do not have any major health issues that would prevent me from having surgery.

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I have not received a high dose of anthracycline chemotherapy.

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I had HIPEC treatment within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population

Secondary study objectives

Disease-free survival (DFS)

Hospital length of stay

Incidence of morbidity

+4 more

Side effects data

From 2023 Phase 2 trial • 24 Patients • NCT02891447

70%

Grade II

30%

Grade III

Grade IV

Grade I

100%

80%

60%

40%

20%

Study treatment Arm

Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cytoreduction, HIPEC)Experimental Treatment9 Interventions

Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate IV over 12 hours. Patients also undergo CT scan, MRI or PET/CT scan and blood sample collection throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Computed Tomography

2017

Completed Phase 2

~2790

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030

Cisplatin

2013

Completed Phase 3

~3120

Cytoreductive Surgery

2011

Completed Phase 2

~200

Doxorubicin

2012

Completed Phase 3

~8030

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210

Sodium Thiosulfate

2017

Completed Phase 3

~120

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,362 Previous Clinical Trials

3,065,959 Total Patients Enrolled

20 Trials studying Sarcoma

2,175 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,957 Previous Clinical Trials

41,112,115 Total Patients Enrolled

460 Trials studying Sarcoma

229,839 Patients Enrolled for Sarcoma

Patricio C. Gargollo, M.D.5.050 ReviewsPrincipal Investigator - Mayo Clinic

Mayo Clinic

5Patient Review

We came to see Dr. Gargollo for a second opinion regarding options after a secondary UPJ obstruction. Dr. Gargollo had taken the time to become familiar with our particular situation before our appointment, and was compassionate, comforting, and very well-informed about our condition. He explained treatment options in very clear terms and his clinical judgement has brought us through this health challenge with great success. I highly recommend Dr. Gargollo for both his personal manner and his

Patricio C GargolloPrincipal InvestigatorMayo Clinic