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HIPEC for Ovarian Cancer (HOTT Trial)

Phase 3

Recruiting

Research Sponsored by GOG Foundation

Eligibility Criteria Checklist

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

Must have

Patient must be age > 18

Patients must have a GOG performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the time of death or date of last contact, assessed up to 8 years

Awards & highlights

HOTT Trial Summary

This trial involves registering patients for chemotherapy before, during, or after surgery. Patients who do not respond well to the initial chemotherapy will be removed from the study. After completing chemotherapy, patients will undergo surgery

Who is the study for?

This trial is for patients with advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. They must have completed neoadjuvant chemotherapy and be candidates for surgery without large remaining tumors. Participants need normal organ function tests and a specific genetic test result before joining.Check my eligibility

What is being tested?

The study compares two approaches after initial chemo: one group receives heated intraperitoneal chemotherapy (HIPEC) with cisplatin during surgery, while the other does not. Both groups get more chemo post-surgery and then niraparib until disease progression or up to 36 months.See study design

What are the potential side effects?

Possible side effects include reactions to platinum-based drugs like nausea, kidney issues, nerve damage (neuropathy), blood cell count changes leading to increased infection risk, fatigue, and complications from the HIPEC procedure itself.

HOTT Trial Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood tests show enough hemoglobin, neutrophils, and platelets.

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My nerve damage does not severely affect my daily activities.

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I have no visible cancer larger than 1 cm after initial surgery.

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My liver tests are within the required limits.

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I have advanced ovarian, fallopian tube, or peritoneal cancer and am a candidate for surgery after chemotherapy.

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My scans show no signs of cancer outside my abdomen after treatment.

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My kidney function is normal, with creatinine ≤ 1.3mg/dl and clearance ≥ 30 mL/min.

HOTT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the time of death or date of last contact, assessed up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the time of death or date of last contact, assessed up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the time of death or date of last contact, assessed up to 8 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

Progression-free survival

Secondary outcome measures

Effect of homologous recombination repair deficiency

Frequency and severity of adverse events

Overall Survival

+3 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)

HOTT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HIPECExperimental Treatment1 Intervention

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cisplatin 100 mg/m2 IP over 90 minutes at 42 degrees C

Group II: No HIPECActive Control1 Intervention

No treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor

42 Previous Clinical Trials

16,511 Total Patients Enrolled

8 Trials studying Ovarian Cancer

3,279 Patients Enrolled for Ovarian Cancer

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,605 Total Patients Enrolled

24 Trials studying Ovarian Cancer

16,450 Patients Enrolled for Ovarian Cancer

Oliver Zivanovic, MDStudy ChairGOG Foundation

3 Previous Clinical Trials

418 Total Patients Enrolled

3 Trials studying Ovarian Cancer

418 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

What is the current number of individuals undergoing treatment within this medical study?

"To successfully conduct the investigation, 230 individuals who fit within the specified eligibility criteria are needed. The trial will be overseen by GlaxoSmithKline and carried out at various locations such as Jefferson Hospital in Jefferson Hills, Pennsylvania and Hoag Memorial Hospital Presbyterian in Newport Beach, California."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"At present, patient recruitment is ongoing at 9 diverse trial sites. These include Jefferson Hills, Newport Beach, and Lexington among others. Opting for the closest location to your residence can help reduce travel burdens during potential participation."

Answered by AI

Is this research study currently accepting new participants?

"Indeed, information on clinicaltrials.gov indicates that this research is actively seeking individuals to participate. Initially shared on March 1st, 2024, and most recently revised on February 21st, 2024, the trial aims to recruit a total of 230 participants from nine distinct sites."

Answered by AI

What is the level of risk associated with HIPEC treatment for individuals?

"On a scale of 1 to 3, our team at Power assesses the safety of HIPEC as a 3 due to its Phase 3 trial status. This indicates that there is existing data confirming effectiveness and several sets of data ensuring safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

2024. "Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659381.

All > Peritoneal Carcinomatosis