Study on Radspherin® for Patients with Advanced Epithelial Cancer with Peritoneal Metastasis Undergoing Chemotherapy and Surgery

Sponsor: Oncoinvent AS

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06504147

Provider View

This clinical trial is testing the safety and effectiveness of a single injection of Radspherin® in patients with advanced ovarian, fallopian tube, or peritoneal cancer that has spread to the peritoneum. The study involves patients who are scheduled for chemotherapy and surgery to remove the cancer.

Patient Parameters

Program Overview

This study is designed to evaluate the safety and effectiveness of Radspherin®, a treatment given directly into the abdomen, for patients with advanced ovarian, fallopian tube, or peritoneal cancer that has spread to the peritoneum. The study is conducted in two parts: an initial safety phase followed by a randomized phase. All participants will receive chemotherapy and surgery to remove the cancer, and the goal is to achieve complete removal of the tumor. Patients will undergo the same procedures and assessments throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with advanced high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
  • Cancer has spread to the peritoneum and is eligible for surgery to remove all visible tumors.
  • Have recovered from any side effects of previous cancer treatments.
  • Confirmed to have a specific genetic profile (HR proficient).
  • Completed 3 or 4 cycles of chemotherapy with stable or reduced cancer on scans and assessed as operable.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate kidney, liver, and bone marrow function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.

Exclusion Criteria

  • Known genetic mutations (BRCA1 or BRCA2) or HR deficiency.
  • Suspected issues with the abdominal area that could affect treatment.
  • Certain types of ovarian cancer or recurrent cancer.
  • Cancer that has spread to the brain causing symptoms.
  • Another cancer within the past 3 years, except for certain skin or cervical cancers.
  • Previous radiation therapy to the abdomen or pelvis.
  • Cancer progression during initial chemotherapy.
  • Pregnant or breastfeeding women.
  • Active infections or fever requiring treatment.
  • Active liver disease or certain viral infections.
  • Severe heart conditions.
  • Any condition that could compromise safety or study results.
  • Recent participation in another clinical trial or treatment with investigational drugs.
  • Recent treatment with certain cancer therapies.

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