Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study

Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study: Conditions:   Malignant Abdominal Neoplasm;   Malignant Pelvic Neoplasm;   Recurrent Colon Carcinoma;   Recurrent Desmoplastic Small Round Cell Tumor;   Recurrent Fallopian Tube Carcinoma;   Recurrent Gastric Carcinoma;   Recurrent Liposarcoma;   Recurrent Malignant Mesothelioma;   Recurrent Ovarian Carcinoma;   Recurrent Primary Peritoneal Carcinoma;   Recurrent Rectal Carcinoma;   Recurrent Rhabdomyosarcoma;   Recurrent Sarcoma;   Refractory Colon Carcinoma;   Refractory Desmoplastic Small Round Cell Tumor;   Refractory Fallopian Tube Carcinoma;   Refractory Gastric Carcinoma;   Refractory Liposarcoma;   Refractory Malignant Mesothelioma;   Refractory Ovarian Carcinoma;   Refractory Primary Peritoneal Carcinoma;   Refr...




Hide glossaryGlossary

Study record managers: refer to the Data Element Definitions if submitting registration or results information.



Search for terms



x

Accepts healthy volunteers

Active comparator arm

Adverse event

Age or age group

All-cause mortality

Allocation

Arm

Arm type

Baseline characteristics

Canceled submission

Certain agreements

Certification

Certification/extension first posted

Certification/extension first submitted

Certification/extension first submitted that met QC criteria

City and distance

Clinical study

Clinical trial

ClinicalTrials.gov identifier (NCT number)

Collaborator

Condition/disease

Contact

Country

Cross-over assignment

Data Monitoring Committee (DMC)

Early Phase 1 (formerly listed as Phase 0)

Eligibility criteria

Enrollment

Exclusion criteria

Expanded access

Expanded access status

Expanded access type

Experimental arm

Extension request

Factorial assignment

First posted

First submitted

First submitted that met QC criteria

Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)

Funder type

Gender-based eligibility

Group/cohort

Human subjects protection review board

Inclusion criteria

Informed consent

Informed consent form (ICF)

Intervention model

Intervention/treatment

Interventional study (clinical trial)

Investigator

Last update posted

Last update submitted

Last update submitted that met QC criteria

Last verified

Listed location countries

Location terms

Masking

NCT number

No intervention arm

Observational study

Observational study model

Other adverse event

Other study IDs

Other terms

Outcome measure

Parallel assignment

Participant flow

Patient registry

Phase

Phase 1

Phase 2

Phase 3

Phase 4

Phase Not Applicable

Placebo

Placebo comparator arm

Primary completion date

Primary outcome measure

Primary purpose

Principal investigator (PI)

Protocol

Quality control (QC) review

Randomized allocation

Recruitment status

Registration

Removed location countries

Reporting group

Responsible party

Results database

Results delayed

Results first posted

Results first submitted

Results first submitted that met QC criteria

Results returned after quality control review

Results submitted to ClinicalTrials.gov

Secondary outcome measure

Serious adverse event

Sex

Sham comparator arm

Single group assignment

Sort studies by

Sponsor

State

Statistical analysis plan (SAP)

Status

Study completion date

Study design

Study documents

Study IDs

Study record

Study registry

Study results

Study start date

Study type

Submitted date

Title

Title acronym

U.S. Agency for Healthcare Research and Quality (AHRQ)

U.S. Food and Drug Administration (FDA)

Unknown

Skip to Main Content

ClinicalTrials.gov

Find StudiesFind Studies Menu

About StudiesAbout Studies Menu

Submit StudiesSubmit Studies Menu

ResourcesResources Menu

About SiteAbout Site Menu

HomeSearch ResultsStudy Record Detail Save this study

Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04213794

Recruitment Status  : Recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

Mayo Clinic

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Mayo Clinic



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

Go to  sections

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. Drugs used in chemotherapy, 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.



Condition or disease Intervention/treatment Phase

Malignant Abdominal Neoplasm

Malignant Pelvic Neoplasm

Recurrent Colon Carcinoma

Recurrent Desmoplastic Small Round Cell Tumor

Recurrent Fallopian Tube Carcinoma

Recurrent Gastric Carcinoma

Recurrent Liposarcoma

Recurrent Malignant Mesothelioma

Recurrent Ovarian Carcinoma

Recurrent Primary Peritoneal Carcinoma

Recurrent Rectal Carcinoma

Recurrent Rhabdomyosarcoma

Recurrent Sarcoma

Refractory Colon Carcinoma

Refractory Desmoplastic Small Round Cell Tumor

Refractory Fallopian Tube Carcinoma

Refractory Gastric Carcinoma

Refractory Liposarcoma

Refractory Malignant Mesothelioma

Refractory Ovarian Carcinoma

Refractory Primary Peritoneal Carcinoma

Refractory Rectal Carcinoma

Refractory Rhabdomyosarcoma

Refractory Sarcoma

Resectable Liposarcoma

Resectable Malignant Mesothelioma

Resectable Sarcoma

Drug: Cisplatin

Procedure: Cytoreductive Surgery

Drug: Doxorubicin

Drug: Hyperthermic Intraperitoneal Chemotherapy

Drug: Sodium Thiosulfate

Early Phase 1



Detailed Description:

PRIMARY OBJECTIVES:



I. 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.



II. To assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.



SECONDARY OBJECTIVE:



I. Evaluate disease recurrence patterns: locoregional versus distant.



OUTLINE:



Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate intravenously (IV) over 12 hours.



After completion of the study treatment, patients are followed every 6 months for 5 years.





Study Design

Go to  sections

Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 43 participants

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Official Title: 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)

Actual Study Start Date  : December 1, 2019

Estimated Primary Completion Date  : January 30, 2025

Estimated Study Completion Date  : January 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma Soft Tissue Sarcoma Ovarian Cancer Ovarian Epithelial Cancer Liposarcoma Fallopian Tube Cancer Stomach Cancer Desmoplastic Small Round Cell Tumor

U.S. FDA Resources



Arms and Interventions

Go to  sections

Arm Intervention/treatment

Experimental: Treatment (cytoreduction, HIPEC)

Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate IV over 12 hours.

Drug: Cisplatin

Undergo HIPEC with doxorubicin and cisplatin

Other Names:

Abiplatin

Blastolem

Briplatin

CDDP

Cis-diammine-dichloroplatinum

Cis-diamminedichloridoplatinum

Cis-diamminedichloro Platinum (II)

Cis-diamminedichloroplatinum

Cis-dichloroammine Platinum (II)

Cis-platinous Diamine Dichloride

Cis-platinum

Cis-platinum II

Cis-platinum II Diamine Dichloride

Cismaplat

Cisplatina

Cisplatinum

Cisplatyl

Citoplatino

Citosin

Cysplatyna

DDP

Lederplatin

Metaplatin

Neoplatin

Peyrone''s Chloride

Peyrone''s Salt

Placis

Plastistil

Platamine

Platiblastin

Platiblastin-S

Platinex

Platinol

Platinol- AQ

Platinol-AQ

Platinol-AQ VHA Plus

Platinoxan

Platinum

Platinum Diamminodichloride

Platiran

Platistin

Platosin



Procedure: Cytoreductive Surgery

Undergo cytoreduction

Other Name: Cytoreduction



Drug: Doxorubicin

Undergo HIPEC with doxorubicin and cisplatin

Other Names:

Adriablastin

Hydroxydaunomycin

Hydroxyl Daunorubicin

Hydroxyldaunorubicin



Drug: Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC with doxorubicin and cisplatin

Other Name: HIPEC



Drug: Sodium Thiosulfate

Given IV

Other Names:

Cyanide Antidote Package

Disodium thiosulfate

S-Hydril

Sodium Hyposulfate

Sodium Thiosulfate Pentahydrate

Sodium Thiosulphate

Sodothiol

Thiosulfate, Sodium, Pentahydrate

Thiosulfuric Acid Disodium Salt







Outcome Measures

Go to  sections

Primary Outcome Measures  :

Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population [ Time Frame: Up to 6 months ]

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.





Secondary Outcome Measures  :

Overall survival (OS) [ Time Frame: From the time of diagnosis of cancer up, assessed to 5 years ]

Will be estimated using the Kaplan-Meier method. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.



Disease-free survival (DFS) [ Time Frame: From the time of diagnosis of cancer up to 5 years ]

Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.



Peritoneal-free recurrence [ Time Frame: From the time of diagnosis of cancer up to 5 years ]

Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.



Incidence of morbidity [ Time Frame: 30, 60, and, 90 days post-HIPEC procedure ]

Will be measured using the Clavien Dindo scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.



Incidence of mortality [ Time Frame: 30 days post-HIPEC procedure ]

Will be tracked using NCI CTCAE version 5.



Hospital length of stay [ Time Frame: Up to 5 years ]

Will be tracked using NCI CTCAE version 5.



Estimated blood loss (EBL) [ Time Frame: Up to 5 years ]

Operative time [ Time Frame: Up to 5 years ]

Progression free survival (PFS) [ Time Frame: From the time protocol treatment is initiated, assessed up to 5 years ]

The PFS is defined as the time between initiation of protocol treatment and the first occurrence of disease. It will be defined radiologically.





Eligibility Criteria

Go to  sections

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  1 Year to 25 Years   (Child, Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:



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 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 may be excluded based on the assessment of risk by our radiation oncology team

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)

Neutrophil count >= 750 (performed no later than 14 days before surgery)

Patients must have adequate renal function defined as creatinine clearance (performed no later than 14 days before surgery) or radioisotope GFR (glomerular filtration rate) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender less than the following values:



1 to < 2 years 0.6mg/dL for both males and females

2 to < 6 years 0.8mg/dL for both males and females

6 to <10 years 1.0mg/dL for both males and females

A signed informed consent form (and assent form when appropriate) approved by the Mayo Clinic (Institutional Review Board [IRB]) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study

Exclusion Criteria:



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

Contacts and Locations

Go to  sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213794





Locations

United States, Minnesota

Mayo Clinic Recruiting

Rochester, Minnesota, United States, 55905

Contact: Clinical Trials Referral Office    855-776-0015     

Principal Investigator: Patricio C. Gargollo       

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator: Patricio C Gargollo Mayo Clinic

More Information

Go to  sections



Additional Information:

Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site



Responsible Party: Mayo Clinic

ClinicalTrials.gov Identifier: NCT04213794     History of Changes

Other Study ID Numbers: MC1947

NCI-2019-08650 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )

MC1947 ( Other Identifier: Mayo Clinic )

P30CA015083 ( U.S. NIH Grant/Contract )

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma

Sarcoma

Mesothelioma

Rhabdomyosarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lung Neoplasms

Liposarcoma

Fallopian Tube Neoplasms

Stomach Neoplasms

Rectal Neoplasms

Desmoplastic Small Round Cell Tumor

Colonic Neoplasms

Abdominal Neoplasms

Pelvic Neoplasms

Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Adenoma

Neoplasms, Mesothelial

Myosarcoma

Neoplasms, Muscle Tissue

Endocrine Gland Neoplasms

Neoplasms by Site

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Neoplasms, Female

Urogenital Neoplasms





TO TOP

For Patients and Families For Researchers For Study Record Managers

HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT

Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov

U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services