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Brachytherapy

Radspherin for Ovarian Cancer

Phase 2

Recruiting

Research Sponsored by Oncoinvent AS

Eligibility Criteria Checklist

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

Must have

Completed 3 or 4 cycles of NACT with regress or stable disease on diagnostic imaging and assessed to be operable to R0

Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV)

Must not have

Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease

Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

"This trial aims to test the effectiveness and safety of a single intraperitoneal injection of Radspherin® in patients with advanced ovarian, fallopian tube, or peritoneal cancer that

Who is the study for?

This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer that has spread to the lining of the abdomen and are able to undergo chemotherapy and surgery. Participants must have a specific type of tumor (high-grade serous or endometrioid) that repairs DNA normally (HR proficient).

What is being tested?

The study tests Radspherin®, given as a single injection into the abdomen, in two parts: first assessing safety in a small group, then randomly assigning participants to receive Radspherin® or not alongside standard treatment. All patients will have chemotherapy and surgery aimed at removing all visible tumor.

What are the potential side effects?

Specific side effects of Radspherin® aren't detailed here but may include typical reactions related to intraperitoneal injections such as abdominal pain, infection risk increase, possible inflammation around the injection site, and general discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I've finished 3 or 4 rounds of chemo with no cancer growth and can have surgery to remove all cancer.

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My cancer is advanced ovarian, fallopian tube, or peritoneal and is high-grade.

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My cancer is HR proficient according to Myriad MyChoice CDx test.

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My liver tests are within the required range.

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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I can perform daily activities and am fit for surgery and further treatment.

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My kidney function, measured by creatinine clearance, is adequate.

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I am a woman who can have children and have a negative pregnancy test.

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My cancer has spread, but it can be surgically removed completely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had serious heart failure.

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I haven't received any cancer treatments other than the study treatment 4 weeks before or after surgery.

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I do not have any active infections needing antibiotics or causing fever over 38.0°C.

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I have a known BRCA1 or BRCA2 mutation or my cancer is HR deficient.

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My ovarian cancer is not one of the common types.

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I have symptoms from cancer spread to my brain.

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I have had radiotherapy to my abdomen or pelvis before.

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I do not have active liver disease or a positive test for hepatitis B, C, or HIV.

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I haven't taken any experimental drugs within the last 4 weeks.

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I have not received bevacizumab within the last 5 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

Peritoneal progression free survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RadspherinExperimental Treatment1 Intervention

Group II: ControlActive Control1 Intervention

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oncoinvent ASLead Sponsor

2 Previous Clinical Trials

116 Total Patients Enrolled

1 Trials studying Peritoneal Carcinomatosis

49 Patients Enrolled for Peritoneal Carcinomatosis

~76 spots leftby Feb 2028

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