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HIPEC After Surgery for Ovarian Cancer

Phase 1

Recruiting

Led By Jill Whyte, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed cancer of the ovary, fallopian tube or peritoneum

Disease limited to the abdomen and pelvis that is amenable to complete CRS indicated by:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is for women with ovarian, fallopian tube, or primary peritoneal cancer who have undergone 3 cycles of neoadjuvant chemotherapy and are eligible for cytoreductive surgery. The trial will evaluate the feasibility, toxicity, and tolerability of heated intraoperative peritoneal chemotherapy administered after neoadjuvant chemotherapy.

Who is the study for?

This trial is for women over 18 with ovarian, fallopian tube, or peritoneal cancer who've had a positive response to initial chemotherapy. They must be in good heart and lung health, not pregnant or breastfeeding, without other cancers or severe illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial tests heated intraoperative peritoneal chemotherapy (HIPEC) after three cycles of neoadjuvant chemotherapy (NACT) and surgery in patients whose tumors can potentially be completely removed. The focus is on feasibility and safety of HIPEC post-NACT.See study design

What are the potential side effects?

Potential side effects include those related to cisplatin such as kidney damage, hearing loss, nerve issues like numbness or tingling, nausea and vomiting. Surgery-related risks may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer originates from the ovary, fallopian tube, or peritoneum.

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My disease is only in my abdomen and pelvis and can be fully removed by surgery.

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My cancer is only in the lining of my abdomen.

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My cancer has not spread to distant parts of my body.

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My liver tests are within the normal range.

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My kidney function, measured by creatinine levels, is normal or nearly normal.

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My heart and lung health is good enough for major surgery.

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I am older than 18 years.

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I can perform all self-care but cannot work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morbidity, assessed by the occurrence of adverse events and serious adverse events

Mortality

Safety data obtained from scheduled exams

Secondary outcome measures

Ability to complete systemic IV chemotherapy after IDS and HIPEC

Achievement of hyperthermia

Completeness of surgical cytoreduction

+2 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: HIPECExperimental Treatment1 Intervention

Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

471,028 Total Patients Enrolled

Katie Oppo Research FundUNKNOWN

Jill Whyte, MD4.413 ReviewsPrincipal Investigator - Northwell Health

Northwell Health

5Patient Review

Dr. Whyte was highly recommended to me by my gynecologist, and she did not disappoint. She was the consummate professional, and made me feel like I was her only patient. I would recommend her to anyone.

Media Library

Cisplatin Clinical Trial Eligibility Overview. Trial Name: NCT03540017 — Phase 1

Ovarian Cancer Research Study Groups: HIPEC

Ovarian Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03540017 — Phase 1

Cisplatin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03540017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include participants aged 18 or above?

"This medical experiment is currently sourcing participants who are between the ages of 18 and 85."

Answered by AI

What regulatory approval has Cisplatin obtained?

"Cisplatin's safety is deemed to be relatively low, as evidenced by its score of 1. This reflects the fact that it is in Phase 1 trials and there are only preliminary indications of efficacy and safety."

Answered by AI

In what medical scenarios is Cisplatin typically prescribed?

"Cisplatin is the usual course of action for treating advanced ovarian cancer and can also be an effective solution for managing refractory, advance testicular cancer as well as certain directives."

Answered by AI

What purpose does this assessment aim to fulfill?

"The key endpoint of this 30-day experiment is to observe safety based on scheduled examinations. Secondary goals include the duration from surgery date until disease progression or mortality due to any cause (Progression-free survival), reaching an intraperitoneal temperature between 41 and 43°C (Achievement of hyperthermia) as well as achieving a Complete cytoreduction score of 0 or 1(Completeness of surgical cytoreduction)."

Answered by AI

Can you provide an overview of the additional experiments completed concerning Cisplatin?

"At present, 689 clinical trials are being conducted around the world to evaluate Cisplatin. Of these studies, 274 have advanced to Phase 3. Most of this research is taking place in Shanghai; however there are 43235 locations where testing for this medication is occuring."

Answered by AI

Are there any open registration slots for this experiment?

"Indeed. According to clinicaltrials.gov, the trial is actively seeking enrollees and this was last updated on November 1st 2022. The initial post date of March 12th 2019 indicates that 15 participants are being sought by a single medical centre."

Answered by AI

To what extent is this experiment populated with participants?

"Affirmative. Contained on clinicaltrials.gov is the information that this medical trial, which was posted in March of 2019, is presently recruiting patients. Altogether 15 individuals are needed to be recruited from 1 site."

Answered by AI