Hyperthermic intraperitoneal chemotherapy for Ovarian Cancer

Mercy Medical Center, Baltimore, MD
Ovarian Cancer+6 More ConditionsHyperthermic intraperitoneal chemotherapy - Procedure
18 - 80
What conditions do you have?

Study 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.

Eligible Conditions
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Stage III Ovarian Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

30 days post-operative
Post-operative complication rates
Year 1
Assessment of quality of life
During & at study completion
Risk factors for morbidity and mortality
Year 5
Evaluate overall survival
at 24 months
Evaluate the rate of progression free survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
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.

Trial Design

2 Treatment Groups

CRS with adjuvant IV/IP chemotherapy
1 of 2
CRS/HIPEC with adjuvant IV chemotherapy
1 of 2

Active Control

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Hyperthermic intraperitoneal chemotherapy · No Placebo Group · Phase 2

CRS/HIPEC with adjuvant IV chemotherapyExperimental Group · 6 Interventions: Hyperthermic intraperitoneal chemotherapy, Carboplatin, Paclitaxel, Cytoreductive Surgery (CRS), Questionnaire, Adjuvant Chemotherapy · Intervention Types: Procedure, Drug, Drug, Procedure, Other, Drug
CRS with adjuvant IV/IP chemotherapyActiveComparator Group · 5 Interventions: Paclitaxel, Cisplatin, Cytoreductive Surgery (CRS), Questionnaire, Adjuvant Chemotherapy · Intervention Types: Drug, Drug, Procedure, Other, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
Cytoreductive Surgery (CRS)
Completed Phase 2
Adjuvant Chemotherapy
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

Who is running the clinical trial?

Mercy Medical CenterLead Sponsor
20 Previous Clinical Trials
3,390 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

Eligibility Criteria

Age 18 - 80 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms and signs of ovarian, fallopian tube, or primary peritoneal cancer.
You have an advanced stage of the disease.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.