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Alkylating agents
HIPEC for Peritoneal Cancer
Phase 1
Recruiting
Led By Andrew M Blakely, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmation of peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or peritoneal mesothelioma histologies by the Laboratory of Pathology, NCI.
Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death or 5 years post-treatment
Awards & highlights
Study Summary
This trial is testing if different chemotherapy drugs used during HIPEC can improve outcomes for people with peritoneal carcinomatosis.
Who is the study for?
Adults over 18 with peritoneal carcinomatosis from ovarian, colorectal, appendiceal, or mesothelioma cancers that can't be fully removed by surgery. They must have good physical function and organ health, not received certain treatments recently, agree to use contraception and co-enroll in a tissue collection study.Check my eligibility
What is being tested?
The trial is testing the effectiveness of heated chemotherapy (HIPEC) after tumor-removing surgery (CRS). Different chemo drugs are used based on a model called SMART System to see if they improve outcomes for patients with tumors spread within the abdomen lining.See study design
What are the potential side effects?
Possible side effects include reactions to platinum-based drugs like Cisplatin or Doxorubicin such as nausea, kidney issues, hearing loss; blood count changes due to Mitomycin C; nerve damage from Oxaliplatin; mouth sores and diarrhea from 5-Fluorouracil.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, originating from the appendix, colon, ovary, or peritoneum, has spread within the abdomen.
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My cancer's growth can be measured or evaluated.
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I am fully active and can carry on all pre-disease activities without restriction.
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My blood counts and liver/kidney functions are within normal ranges.
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My doctor believes I can have all visible cancer removed, with a PCI score of 30 or less.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ death or 5 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~death or 5 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the correlation between ex vivo simulated HIPEC in the SMART system and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67
Secondary outcome measures
To determine the correlation between ex vivo simulated HIPEC in the SMART System and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67, separately within each cohort and arm subset, as well as within...
To estimate the peritoneal progression-free survival probability as a function of tissue response to ex vivo simulated HIPEC in the SMART System and in vivo HIPEC, as assessed by percent necrosis and Ki-67, in a preliminary fashion
To estimate the peritoneal progression-free survival probability, separately by arms and by cohorts, in a preliminary fashion
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: 4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignmeExperimental Treatment4 Interventions
HIPEC with intraperitoneal cisplatin and mitomycin C, in addition to IV sodium thiosulfate, randomly assigned
Group II: 3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignmeExperimental Treatment4 Interventions
HIPEC with intraperitoneal cisplatin and doxorubicin, in addition to IV sodium thiosulfate, randomly assigned
Group III: 2/ HIPEC: Mitomycin C Randomized treatment assignmentExperimental Treatment2 Interventions
HIPEC with intraperitoneal mitomycin C, randomly assigned
Group IV: 1/ HIPEC: Oxaliplatin Randomized treatment assignmentExperimental Treatment3 Interventions
HIPEC with intraperitoneal oxaliplatin and IV 5-FU, randomly assigned
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2014
Completed Phase 3
~90
Cisplatin
2013
Completed Phase 3
~1940
Doxorubicin
2012
Completed Phase 3
~7940
Oxaliplatin
2011
Completed Phase 4
~2560
Mitomycin C
2019
Completed Phase 4
~820
5-Fluorouracil
2012
Completed Phase 3
~7800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,845 Total Patients Enrolled
13 Trials studying Peritoneal Carcinomatosis
423 Patients Enrolled for Peritoneal Carcinomatosis
Andrew M Blakely, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
470 Total Patients Enrolled
1 Trials studying Peritoneal Carcinomatosis
70 Patients Enrolled for Peritoneal Carcinomatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive with an undetectable viral load and on antiretroviral therapy.My cancer, originating from the appendix, colon, ovary, or peritoneum, has spread within the abdomen.My cancer's growth can be measured or evaluated.I am fully active and can carry on all pre-disease activities without restriction.My blood counts and liver/kidney functions are within normal ranges.I haven't had cancer treatment in the last 4 weeks.I am allergic to medications that contain platinum.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My doctor believes I can have all visible cancer removed, with a PCI score of 30 or less.I have not had major surgery in the last 12 weeks.I am 18 years old or older.My cancer has spread beyond my abdomen from my appendix, colon, ovary, or the lining of my abdomen.I have a genetic deficiency related to my appendiceal or colorectal cancer.I am not pregnant or breastfeeding as the treatment involves major surgery and drugs that could harm a baby.
Research Study Groups:
This trial has the following groups:- Group 1: 4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignme
- Group 2: 3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignme
- Group 3: 1/ HIPEC: Oxaliplatin Randomized treatment assignment
- Group 4: 2/ HIPEC: Mitomycin C Randomized treatment assignment
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.
How many individuals are involved in the experiment?
"Affirmative. Clinicaltrials.gov reveals that this study, first posted on October 19th 2021, is recruiting patients at present. A total of 60 subjects need to be recruited from a single medical centre for the trial's success."
Answered by AI
Is this clinical trial open for enrolment?
"Affirmative. Clinicaltrials.gov details that this study, which was initially posted on October 19th 2021 is now recruiting participants. Approximately 60 patients are to be recruited from one medical centre."
Answered by AI
Is this experiment novel in its approach?
"A total of 2346 trials have been conducted since the inception of Heated Intraperitonial Chemotherapy studies in 1997. As it stands, 1436 are active and sprawled across 78 nations with 3902 cities involved. Alfacell initially spearheaded a Phase 3 study which included 300 participants."
Answered by AI
What ailments are addressed by the application of Heated Intraperitonial Chemotherapy?
"Heated Intraperitonial Chemotherapy is the main treatment approach used to manage neoplasms. This procedure can also reduce symptoms associated with colorectal neoplasms, actinic keratosis and acute lymphoblastic leukemia (ALL)."
Answered by AI
Has heated intraperitoneal chemotherapy been previously evaluated in clinical studies?
"Currently, 1436 clinical trials are studying the potential benefits of Heated Intraperitonial Chemotherapy with 518 Phase 3 trials. Most of these studies originate out of Guangzhou, Guangdong yet there also exist 81016 other medical facilities conducting research on this topic."
Answered by AI
Has the FDA granted permission for Heated Intraperitonial Chemotherapy?
"Limited clinical data confirms the safety of Heated Intraperitonial Chemotherapy, so it was assigned a rating of 1."
Answered by AI
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