Heated Chemotherapy for Abdominal Cancer

(TOASTIT Trial)

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Metastatic disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This early phase I trial studies how well heated intra-peritoneal chemotherapy with doxorubicin and cisplatin work for the treatment of abdominal or pelvic tumors that can be removed by surgery (resectable), does not respond to treatment (refractory), or has come back (recurrent). Heated intra-peritoneal chemotherapy is a procedure performed in combination with abdominal surgery for cancer that has spread to the abdomen. It involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Chemotherapy drugs, such as doxorubicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more cells.

Research Team

Patricio C. Gargollo, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

My cancer type is listed among specific types like ovarian or colon cancer.

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

My tumor can be surgically removed, is either not responding to treatment or has come back, and measures at least 1 cm.

Exclusion Criteria

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

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

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection and HIPEC Treatment

Patients undergo cytoreduction followed by heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin and cisplatin over 60 minutes. Patients then receive sodium thiosulfate IV over 12 hours.

1 week

Inpatient hospital stay

Post-Treatment Monitoring

Patients are monitored for adverse events and complications, including morbidity and mortality, using NCI CTCAE version 5.

Up to 6 months

Regular follow-up visits

Long-term Follow-up

Participants are followed every 6 months for 5 years to assess overall survival, disease-free survival, and progression-free survival.

5 years

Bi-annual visits

Treatment Details

Interventions

• Cisplatin
• Cytoreductive Surgery
• Doxorubicin
• Hyperthermic Intraperitoneal Chemotherapy

Trial Overview 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.

Participant Groups

Group I: Treatment (cytoreduction, HIPEC) Experimental Treatment 9 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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+