ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis (ICARuS)
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ClinicalTrials.gov Identifier: NCT01815359 |
Recruitment Status :
Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : February 2, 2024
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Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
The Cleveland Clinic
Brigham and Women's Hospital
University of Miami
University of Pittsburgh Medical Center
Washington University School of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | ||||
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First Submitted Date ICMJE | March 13, 2013 | |||
First Posted Date ICMJE | March 21, 2013 | |||
Last Update Posted Date | February 2, 2024 | |||
Study Start Date ICMJE | March 2013 | |||
Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
disease-free survival [ Time Frame: 3 years ] Documentation of tumor recurrence will be made based on surveillance CT/PET CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
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Original Primary Outcome Measures ICMJE |
disease-free survival [ Time Frame: 3 years ] Documentation of tumor recurrence will be made based on surveillance CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis | |||
Official Title ICMJE | ICARuS (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multi-center, Randomized Phase II Trial of Early Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis | |||
Brief Summary | This is the first randomized trial comparing Early post-operative intraperitoneal chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and colorectal cancer. The purpose of this study is to find out what effects, good and/or bad, EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal, rectal or colon cancer. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Intervention Model Description: After the initial 212 patients are accrued, the final 70 patients will be accrued to only the appendiceal cohorts Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
292 | |||
Original Estimated Enrollment ICMJE |
220 | |||
Estimated Study Completion Date ICMJE | September 2026 | |||
Estimated Primary Completion Date | September 2026 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01815359 | |||
Other Study ID Numbers ICMJE | 12-289 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | February 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |