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Alkylating agents
HIPEC + Surgery for Ovarian Cancer (CRS/HIPEC Trial)
Phase 2
Waitlist Available
Led By Teresa Diaz-Montes, M.D.
Research Sponsored by Mercy Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage III/IV disease
Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Awards & highlights
CRS/HIPEC Trial Summary
This trial is testing whether a surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment, is a safe and effective treatment for ovarian, fallopian tube, and primary peritoneal cancer.
Who is the study for?
This trial is for adults with advanced stage (III/IV) ovarian, fallopian tube, or primary peritoneal cancer who haven't had treatment yet. They should be physically able to handle the procedures and have good organ function. Pregnant women, those with certain heart conditions, prior strokes or other cancers in the last 3 years are excluded.Check my eligibility
What is being tested?
The study tests how safe and effective it is to combine cytoreductive surgery (CRS) with heated chemotherapy directly in the abdomen (HIPEC), followed by standard chemo. It's a phase II trial where patients are randomly assigned to treatments at a community hospital.See study design
What are the potential side effects?
Possible side effects include reactions from chemotherapy like nausea, fatigue, hair loss; surgical complications; kidney issues due to medication toxicity; and increased risk of infection.
CRS/HIPEC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is in stage III or IV.
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I am mostly self-sufficient and can carry out daily activities.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My kidney function is within the normal range.
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After surgery to remove as much cancer as possible, less than 1 cm of cancer remains.
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My cancer originates from the ovary, fallopian tube, or peritoneum.
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My liver tests are within the required range.
CRS/HIPEC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative complication rates
Secondary outcome measures
Assessment of quality of life
Evaluate overall survival
Evaluate the rate of progression free survival
Other outcome measures
Risk factors for morbidity and mortality
CRS/HIPEC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CRS/HIPEC with adjuvant IV chemotherapyExperimental Treatment6 Interventions
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
Group II: CRS with adjuvant IV/IP chemotherapyActive Control5 Interventions
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Cytoreductive Surgery (CRS)
2015
Completed Phase 2
~20
Adjuvant Chemotherapy
2015
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Mercy Medical CenterLead Sponsor
20 Previous Clinical Trials
4,190 Total Patients Enrolled
1 Trials studying Ovarian Cancer
438 Patients Enrolled for Ovarian Cancer
Teresa Diaz-Montes, M.D.Principal InvestigatorMercy Medical Center
Armando Sardi, M.D.Principal InvestigatorMercy Medical Center
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on IV antibiotics for an infection.I had a heart attack or other heart issue in the last 6 months.I have moderate to severe heart failure.My kidney function is reduced with high creatinine or low clearance.I have had a stroke or brain artery disease in the last 6 months.My blood pressure is higher than 140/90 and I haven't been cleared for surgery by a heart doctor.I am not pregnant or breastfeeding.My condition is in stage III or IV.I haven't had treatment or major surgery for ovarian, fallopian tube, or peritoneal cancer, but diagnostic laparoscopy is okay.My health allows me to receive chemotherapy after surgery.I have active hepatitis and HIV.I experience chest pain with normal physical activity.I am mostly self-sufficient and can carry out daily activities.My blood tests show normal white blood cells, platelets, and hemoglobin levels.You are expected to live less than 12 weeks.I have had surgery to remove as much of the cancer as possible.I have had treatment for ovarian, fallopian tube, or peritoneal cancer.Your blood clotting tests should be within normal range, and if you are taking warfarin, your blood thinning levels should be in a specific range.Confirmation through tissue sample testing.I have not had any other cancer in the last 3 years.My kidney function is within the normal range.My cancer is in the early stages (Stage I or II).After surgery to remove as much cancer as possible, less than 1 cm of cancer remains.My cancer originates from the ovary, fallopian tube, or peritoneum.My liver tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: CRS with adjuvant IV/IP chemotherapy
- Group 2: CRS/HIPEC with adjuvant IV chemotherapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Does the FDA recognize Hyperthermic intraperitoneal chemotherapy as an accepted treatment?
"Hyperthermic intraperitoneal chemotherapy is at a Phase 2, meaning that while there is safety data, there is no information yet on whether it works. Our team rates it as a 2."
Answered by AI
Can new patients still join this clinical trial?
"Yes, this study is still recruiting patients as of 8/30/2022 according to the clinicaltrials.gov website. The trial was initially posted on 4/1/2014."
Answered by AI
Does this experiment have an age limit? Can elderly persons participate?
"The age criteria for this study stipulate that patients must be over 18 but under 80 years old."
Answered by AI
Who meets the eligibility requirements for this research?
"Eligibility criteria for this ovarian cancer clinical trial are being between 18-80 years old. They aim to recruit 48 patients in total."
Answered by AI
What is the most common reason that patients receive hyperthermic intraperitoneal chemotherapy?
"Hyperthermic intraperitoneal chemotherapy is a well-known treatment for advanced endometrial cancer. Other conditions that this method can be used to treat include melanoma, neoplasm metastasis, lymphoma, and non-hodgkin."
Answered by AI
How many people are participating in this clinical trial?
"That is correct, the clinical trial referenced is actively recruiting patients according to information found on clinicaltrials.gov. The original posting was on April 1st, 2014 with the most recent update being on August 30th, 2022. There is a need for 48 patients at a single location."
Answered by AI
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