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Heated Chemotherapy + Niraparib 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
Must not have
Patients with current active liver or biliary disease
Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active liver or biliary disease.
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My ovarian cancer is of a specific type (low-grade serous, clear cell, mucinous, or non-epithelial).
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I have a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.
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I have uncontrolled diabetes or a kidney condition.
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I have hearing loss before starting the trial.
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I have a serious heart condition.
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My cancer progressed during initial treatment, as shown in recent scans.
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I have not had a severe infection needing IV antibiotics in the last 2 weeks.
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My cancer has spread to my brain or spinal cord.
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I have had Reversible Encephalopathy Syndrome in the past.
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I have active hepatitis B.
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I have not received a live vaccine in the last 30 days.
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I've had radiation on more than 20% of my bone marrow within the last 2 weeks.
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My stage IV cancer has not fully responded to treatment and cannot be surgically removed.
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I have significant stomach or intestine issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Effect of homologous recombination repair deficiency

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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~3120

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor
46 Previous Clinical Trials
17,420 Total Patients Enrolled
8 Trials studying Ovarian Cancer
2,905 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,805 Previous Clinical Trials
8,379,273 Total Patients Enrolled
25 Trials studying Ovarian Cancer
16,482 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
~153 spots leftby Aug 2029
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