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Alkylating agents
Heated Chemotherapy for Abdominal Cancer (TOASTIT Trial)
Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
TOASTIT Trial 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.Check my eligibility
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.See study design
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.
TOASTIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to distant parts of my body.
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Cancer cells were found in my abdomen during surgery.
Select...
My kidney function is good, based on recent tests.
Select...
I can care for myself but may not be able to do active work.
Select...
My platelet count is at least 50,000 without transfusions.
Select...
My peritoneal cancer index is 20 or less, and surgeons believe they can remove all my tumor.
TOASTIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population
Secondary outcome measures
Disease-free survival (DFS)
Estimated blood loss (EBL)
Hospital length of stay
+6 moreTOASTIT 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
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1730
Cisplatin
2013
Completed Phase 3
~1940
Cytoreductive Surgery
2011
Completed Phase 1
~150
Doxorubicin
2012
Completed Phase 3
~7940
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Sodium Thiosulfate
2014
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,097 Total Patients Enrolled
15 Trials studying Sarcoma
1,171 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,478 Total Patients Enrolled
453 Trials studying Sarcoma
230,056 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My cancer type is listed among specific types like ovarian or colon cancer.My cancer has not spread to distant parts of my body.I've had a severe allergic reaction to chemotherapy before.I can follow the study's requirements and attend all follow-ups.I do not have any major health issues that would prevent me from having surgery.My tumor can be surgically removed, is either not responding to treatment or has come back, and measures at least 1 cm.Cancer cells were found in my abdomen during surgery.Your blood clotting tests should not be more than 1.2 times the normal levels, and the test should be done within 14 days before surgery.Your alkaline phosphatase level is not more than double the normal range, as checked within 14 days before surgery.My previous cancer treatments don't affect my eligibility, but I might be excluded if radiation therapy raises my risk of complications.Your LDH level is not more than twice the normal range within 14 days before surgery.I have not received a high dose of anthracycline chemotherapy.My kidney function is good, based on recent tests.I can care for myself but may not be able to do active work.My liver enzyme SGOT levels are within twice the normal limit.My platelet count is at least 50,000 without transfusions.Your neutrophil count is 750 or higher within 14 days before surgery.Your bilirubin levels are not more than twice the normal range.I had HIPEC treatment within the last 3 months.My peritoneal cancer index is 20 or less, and surgeons believe they can remove all my tumor.Your SGPT blood test results are not more than twice the normal level.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cytoreduction, HIPEC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility criteria for participating in this trial?
"Eligibility criteria for this clinical trial necessitate that participants suffer from malignant mesothelioma and are between 1 year old to 25 years of age. 43 spots remain available in total."
Answered by AI
Are there current opportunities for individuals to join this research experiment?
"Indeed, the information available on clinicaltrials.gov affirms that this investigation is accepting applicants - it was initially posted in November 2019 and last updated in May 2022. The trial requires 43 participants from 2 sites to be enrolled."
Answered by AI
Is this trial the inaugural experiment of its type?
"At present, 1139 active studies pertaining to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) have been documented in 80 countries and 3465 cities. In 1997, Alfacell initiated the first HIPEC trial which included 300 participants and was successfully completed through Phase 3 drug approval. Since then, 1700 more trials of this nature have been conducted worldwide."
Answered by AI
How many participants are included in this research project?
"Affirmative. According to data hosted on clinicaltrials.gov, this medical research endeavour began recruitment in November of 2019 and is still actively seeking participants. There are 2 sites with a total quota of 43 individuals needed for the trial's completion."
Answered by AI
To what conditions is Hyperthermic Intraperitoneal Chemotherapy commonly applied?
"Hyperthermic Intraperitoneal Chemotherapy is commonly employed to treat cancerous metastases, as well as more advanced cases of thymoma and testicular cancer. Additionally, it has demonstrated efficacy in Hodgkin's lymphoma patients."
Answered by AI
Is this research protocol open to participants aged 55+?
"This medical trial is seeking participants who are between 1 and 25 years of age."
Answered by AI
What other medical experiments have been performed with Hyperthermic Intraperitoneal Chemotherapy?
"Currently, 1139 studies exploring Hyperthermic Intraperitoneal Chemotherapy are active. 415 trials have advanced to Phase 3 and these clinical experiments span 69905 locations with the majority of them situated in Shanghai, China."
Answered by AI
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