Heated Chemotherapy for Abdominal Cancer
(TOASTIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for certain abdominal or pelvic cancers that haven't responded to standard treatments, have recurred, or can be surgically removed. It employs a method called heated intra-peritoneal chemotherapy (HIPEC), where heated chemotherapy drugs, doxorubicin and cisplatin, are infused directly into the abdomen to target more cancer cells. This trial suits individuals with specific abdominal or pelvic tumors who haven't succeeded with other treatments or have experienced a recurrence. As an Early Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that heated intra-peritoneal chemotherapy is safe for treating abdominal cancer?
Research has shown that using cisplatin in heated intra-peritoneal chemotherapy (HIPEC) for advanced ovarian cancer is generally safe. One study found that cisplatin in HIPEC is well-tolerated and does not increase post-surgery complications, suggesting it could be a viable option for treating abdominal cancer.
Regarding doxorubicin, studies indicate that using this drug in HIPEC is also safe. Specifically, one study noted that HIPEC with chemotherapy, such as doxorubicin, does not raise surgery-related risks, allowing patients to handle the treatment well.
Both cisplatin and doxorubicin are used in HIPEC to target cancer cells in the abdomen. The combination of these drugs with heat aims to kill more cancer cells than standard treatments. Although this trial is in an early stage, safety data from similar uses are promising.12345Why do researchers think this study treatment might be promising?
Researchers are excited about this treatment combination because it incorporates a heated chemotherapy process known as HIPEC (Hyperthermic Intraperitoneal Chemotherapy), which is administered directly into the abdominal cavity. Unlike traditional chemotherapy that circulates throughout the body, HIPEC allows for high doses of drugs like cisplatin and doxorubicin to target cancer cells more precisely in the abdomen, potentially reducing systemic side effects. Additionally, the use of heat enhances the efficacy of these drugs by improving their penetration into tissues and increasing their cancer-killing abilities. This innovative approach aims to improve outcomes for patients with abdominal cancer, where conventional treatments often have limited success.
What evidence suggests that heated intra-peritoneal chemotherapy might be an effective treatment for abdominal cancer?
Research has shown that heated intra-peritoneal chemotherapy (HIPEC) can effectively treat abdominal cancers. In this trial, participants will undergo cytoreductive surgery followed by HIPEC treatment. Studies report a significant survival benefit when using cisplatin in HIPEC, with some showing a five-year survival rate as high as 83.3%. Doxorubicin, also used in HIPEC in this trial, has improved survival rates and reduced cancer recurrence without greatly increasing complications. Both drugs kill cancer cells or stop them from growing and spreading. Combining heat with these drugs may enhance their effectiveness by helping them reach tumor cells more effectively.23467
Who Is on the Research Team?
Patricio C. Gargollo, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Post-Treatment Monitoring
Patients are monitored for adverse events and complications, including morbidity and mortality, using NCI CTCAE version 5.
Long-term Follow-up
Participants are followed every 6 months for 5 years to assess overall survival, disease-free survival, and progression-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Cytoreductive Surgery
- Doxorubicin
- Hyperthermic Intraperitoneal Chemotherapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator