Study Stopped
slow accrual
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
TOASTIT
A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy)
3 other identifiers
interventional
2
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Nov 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2019
CompletedFirst Submitted
Initial submission to the registry
December 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2024
CompletedFebruary 20, 2025
February 1, 2025
4.3 years
December 27, 2019
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population
To assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors.
Up to 6 months
Secondary Outcomes (9)
Overall survival (OS)
From the time of diagnosis of cancer up, assessed to 5 years
Disease-free survival (DFS)
From the time of diagnosis of cancer up to 5 years
Peritoneal-free recurrence
From the time of diagnosis of cancer up to 5 years
Incidence of morbidity
30, 60, and, 90 days post-HIPEC procedure
Incidence of mortality
30 days post-HIPEC procedure
- +4 more secondary outcomes
Study Arms (1)
Treatment (cytoreduction, HIPEC)
EXPERIMENTALPatients 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.
Interventions
Undergo HIPEC with doxorubicin and cisplatin
Undergo cytoreduction
Undergo HIPEC with doxorubicin and cisplatin
Undergo HIPEC with doxorubicin and cisplatin
Given IV
Undergo CT scan
Undergo MRI
Undergo PET/CT
Undergo blood sample collection
Eligibility Criteria
You may qualify if:
- Patients must have resectable, primary refractory or recurrent intra-abdominal or pelvic tumors based on imaging studies with measurable disease (\>= 1 cm in 2 perpendicular planes), or primary tumor with peritoneal implants in whom no known other curative treatment exists, and/or patients not on up-front clinical trial
- 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
- Peritoneal cancer index (PCI) =\< 20 and surgeons deem high likelihood of complete residual tumor stage R0 (R0) resection
- No evidence of distant metastases at the time of enrollment
- Histologies to be considered include: rhabdomyosarcoma, liposarcoma, sarcoma (other), ovarian cancer, fallopian tube cancer, gastric cancer, colon cancer, rectal cancer, mesothelioma, and desmoplastic small-round-cell tumor
- Patients must be 1-25 years of age at the time of entry into the study
- Patients may be included in the study independent of the regimen of previous surgical, radiation, or chemotherapy treatments administered. Given the increased risk of entero-cutaneous fistulae observed in patients treated with HIPEC AFTER radiation therapy, patients will be assessed for risk by radiation oncology
- Karnofsky / Lansky performance score of \>= 40 or Eastern Cooperative Oncology Group (ECOG) performance score of 3 or less
- Platelet count \>= 50,000 (independent of transfusion) (performed no later than 14 days before surgery)
- Prothrombin and partial thromboplastin times =\< 1.2 X normal (performed no later than 14 days before surgery)
- Total bilirubin =\< 2 X normal (performed no later than 14 days before surgery)
- Serum glutamic-oxaloacetic transaminase (SGOT) =\< 2 X normal (performed no later than 14 days before surgery)
- Serum glutamate pyruvate transaminase (SGPT) =\< 2 X normal (performed no later than 14 days before surgery)
- Lactate dehydrogenase (LDH) =\< 2 X normal (performed no later than 14 days before surgery)
- Alkaline phosphatase =\< 2 X normal (performed no later than 14 days before surgery)
- +6 more criteria
You may not qualify if:
- Females who are pregnant or breast-feeding during the study period will be excluded
- Distant metastatic disease not limited to peritoneum:
- Solid organ metastases (liver, central nervous system, lung)
- Known bone marrow involvement
- No critical cumulative dose of previous chemotherapy (total anthracycline dose not \>= 435 mg / m\^2)
- Prior HIPEC within 3 months
- 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
- Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, renal failure, cardiovascular failure, pulmonary failure
- Subjects deemed unable to comply with study and/or follow-up procedures
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricio C. Gargollo, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2019
First Posted
December 30, 2019
Study Start
November 8, 2019
Primary Completion
March 4, 2024
Study Completion
October 3, 2024
Last Updated
February 20, 2025
Record last verified: 2025-02