OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy

Launched by SWISS GO TRIAL GROUP · Jun 13, 2024

Keywords

ClinConnect Summary

The OV Precision trial is a research study aimed at finding out if patients with certain types of ovarian cancer can benefit from a personalized cancer therapy that takes into account specific information about their tumors and overall health. This study will specifically look at patients who are newly diagnosed with advanced stages of ovarian tumors and who do not need immediate treatment. By including more detailed tumor information in the treatment decision-making process, researchers hope to improve outcomes for patients who are HRD negative, meaning their tumors do not have specific genetic traits usually targeted by some therapies.

To be eligible for this trial, participants must be women aged 65 to 74 who have been recently diagnosed with certain types of ovarian cancer. They should not require immediate treatment and must be able to attend follow-up visits. Participants will need to give their written consent and should be in relatively good health, as assessed by a specific scale. Throughout the study, participants can expect to contribute to important research that could help improve cancer treatments for future patients. It's also important to note that certain health conditions or treatments may exclude someone from participating, so potential participants should discuss their specific situation with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed EOC (adenocarcinoma of the ovary, peritoneum, and fallopian tube) and carcinosarcoma patients with a suspected FIGO Stage III and IV
• • No immediate need of systemic or surgical treatment at time of and until 2 weeks after diagnosis
• • Envisaged surgical candidate for interval debulking after 2 cycles of treatment
• • Willing and able to attend the visits, to understand the purpose of the trial and all trial-related procedures
• • ECOG 0-2
• • Written informed consent according to national legal and regulatory requirements prior to any project specific procedures
• Exclusion Criteria:
• • Elevated liver enzymes (double of normal range: ASAT \> 68 U/l; ALAT \> 82 U/l; GGT \> 80 U/l)
• • Elevated creatinine (double of normal range: \>120 mmol/l))
• • ECOG ≥3
• • Pregnant or lactating women
• • Any other malignancy within the last 5 years which has an impact on the prognosis of the patient
• • Inability to swallow tablets
• • Concurrent participation in another clinical trial on the same indication
• • Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the sponsor-project leader may interfere with the project or affect patient compliance