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History of Changes for Study: NCT01815359
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
Latest version (submitted February 1, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 18, 2013 None (earliest Version on record)
2 March 27, 2013 Recruitment Status, Study Status and Contacts/Locations
3 April 10, 2013 Arms and Interventions, Study Status and Eligibility
4 April 25, 2013 Study Identification, Eligibility, Conditions and Study Status
5 May 10, 2013 Arms and Interventions, Study Status and Outcome Measures
6 October 9, 2013 Study Status
7 November 7, 2013 Study Status
8 January 2, 2014 Study Status
9 April 24, 2014 Study Status
10 August 14, 2014 Study Status, Contacts/Locations and Eligibility
11 October 14, 2014 Study Status, Eligibility and Outcome Measures
12 December 17, 2014 Study Status and Contacts/Locations
13 July 21, 2015 Study Status, References and Contacts/Locations
14 October 7, 2015 Study Status, Eligibility, Sponsor/Collaborators and Study Identification
15 April 8, 2016 Study Status
16 May 18, 2016 Contacts/Locations, Outcome Measures, Study Status and Sponsor/Collaborators
17 October 19, 2016 Contacts/Locations, Study Status and Sponsor/Collaborators
18 January 4, 2017 Study Status and Eligibility
19 March 16, 2017 Study Status and Contacts/Locations
20 August 3, 2017 Contacts/Locations and Study Status
21 August 17, 2017 Contacts/Locations and Study Status
22 January 17, 2018 Study Status and Contacts/Locations
23 May 7, 2018 Study Status
24 July 18, 2018 Study Status and Eligibility
25 November 8, 2018 Study Status and Contacts/Locations
26 April 2, 2019 Study Status and Sponsor/Collaborators
27 April 3, 2019 Study Status and Contacts/Locations
28 May 8, 2019 Study Status and Contacts/Locations
29 September 24, 2019 Study Design, Study Status, Contacts/Locations and Outcome Measures
30 February 17, 2020 Study Status, Contacts/Locations and Arms and Interventions
31 July 1, 2020 Study Status and Eligibility
32 September 25, 2020 Study Status
33 January 6, 2021 Study Status
34 June 8, 2021 Study Status
35 October 21, 2021 Study Status
36 May 18, 2022 Study Status
37 January 12, 2023 Study Status and Study Design
38 December 4, 2023 Study Status
39 February 1, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01815359
Submitted Date:  March 18, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 12-289
Brief Title: 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: A Single-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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2013
Overall Status: Not yet recruiting
Study Start: March 2013
Primary Completion: March 2018 [Anticipated]
Study Completion: March 2018 [Anticipated]
First Submitted: March 13, 2013
First Submitted that
Met QC Criteria:
March 18, 2013
First Posted: March 21, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 18, 2013
Last Update Posted: March 21, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Memorial Sloan Kettering Cancer Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Appendix Cancer
Colorectal Cancer
Keywords: Intraperitoneal Chemotherapy
hyperthermic intraperitoneal chemotherapy
Optimal Surgical Debulking
Leucovorin
Floxuridine (FUDR)
Mitomycin
12-289
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 220 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Appendiceal, no chemotherapy within 6 months prior to surgery

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the Colorectal Disease Management Team.

  1. Exposure to chemotherapy in the prior 6 months vs. no such exposure
  2. Appendix vs. Colon or Rectum Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.
Procedure: Cytoreductive Surgery
Optimal Surgical Debulking
Drug: HIPEC with MMCDrug: EPIC with FUDR
Experimental: Appendiceal, chemotherapy within 6 months prior to surgery

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the Colorectal Disease Management Team.

  1. Exposure to chemotherapy in the prior 6 months vs. no such exposure
  2. Appendix vs. Colon or Rectum • Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.
Procedure: Cytoreductive Surgery
Optimal Surgical Debulking
Drug: HIPEC with MMCDrug: EPIC with FUDR
Experimental: Colorectal, no chemotherapy within 6 months prior to surgery

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the Colorectal Disease Management Team.

  1. Exposure to chemotherapy in the prior 6 months vs. no such exposure
  2. Appendix vs. Colon or Rectum • Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.
Procedure: Cytoreductive Surgery
Optimal Surgical Debulking
Drug: HIPEC with MMCDrug: EPIC with FUDR
Experimental: Colorectal, chemotherapy within 6 months prior to surgery

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the Colorectal Disease Management Team.

  1. Exposure to chemotherapy in the prior 6 months vs. no such exposure
  2. Appendix vs. Colon or Rectum • Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.
Procedure: Cytoreductive Surgery
Optimal Surgical Debulking
Drug: HIPEC with MMCDrug: EPIC with FUDR
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. surgical toxicity grade 3 to 5
[ Time Frame: up to 60 days ]

We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
2. chemotherapy toxicity grade 4 or 5
[ Time Frame: up to 60 days ]

We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patient's age 18 years or older, both genders.
  • Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or metastasis.
  • Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
  • ECOG performance status ≤ 1.
  • Hematology: ANC ≥ 1.5/ μL; Platelets > 100,000/ μL.
  • Adequate Renal function Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min.
  • Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL).
  • Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
  • A man participating in this study must agree to utilize reliable barrier form of contraception for the duration of the study.
  • Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
  • Subjects with a history of endometrial cancer are eligible only if they presented with a stage lower than 1A and if the histology was a subtype other than poorly differentiated.

Exclusion Criteria:

  • Subjects who have previously undergone complete cytoreduction and/or intraperitoneal chemotherapy.
  • Subjects with classical carcinoid
  • Tumors of low malignant potential
  • Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded.

Other prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.

  • Presence of clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces.
  • Women who are pregnant or lactating.
  • Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
  • Known HIV, Hepatitis B or Hepatitis C positive.
  • Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
  • Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.

Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the time of consent.

  • New York Heart Association (NYHA) Class II or higher Congestive heart failure.
  • Restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
  • History of cerebrovascular disease. that would limit study compliance or place the patient at unacceptable risk for participation in the study.

Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study.

  • Patients with known carboplatin or cisplatin allergy.
  • Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
  • Any condition that would preclude the ability to deliver appropriate IP therapy.
  • Life expectancy < 12 weeks.
Open or close this module Contacts/Locations
Central Contact Person: Garrett Nash, MD, MPH
Telephone: 646-888-3086
Central Contact Backup: Andrea Cercek, MD
Telephone: 646-888-4189
Study Officials: Garrett Nash, MD, MPH
Principal Investigator
Memorial Sloan Kettering Cancer Center
Locations: United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Contact:Contact: Garrett Nash, MD, MPH 646-888-3086
Contact:Contact: Andrea Cercek, MD 646-888-4189
Contact:Principal Investigator: Garrett Nash, MD, MPH
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Memorial Sloan-Kettering Cancer Center
Available IPD/Information:

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