Serous cystadenocarcinoma ovary Trials in Disease

Study of Paclitaxel, Carboplatin and Letrozole Treatment Compared to Letrozole Alone in Patients with Stage II-IV Low-Grade Serous Ovarian or Peritoneal Cancer

This trial is being conducted in Ireland and focuses on a specific type of ovarian cancer called low-grade serous carcinoma. This slow-growing form of cancer typically affects younger women compared to other ovarian cancers and can also involve the peritoneum, which is the lining inside the abdomen.

Main focus of the trial: The study aims to determine whether taking letrozole alone works as well as combining chemotherapy with letrozole maintenance therapy. Letrozole is a hormone therapy medication that helps block estrogen production in the body. Since some ovarian cancers need estrogen to grow, reducing estrogen levels may help slow or stop cancer growth.

Investigational drugs: The trial uses three medications:

• Paclitaxel – a chemotherapy drug given through an intravenous infusion that stops cancer cells from dividing
• Carboplatin – a platinum-based chemotherapy drug also given through intravenous infusion that interferes with cancer cell DNA
• Letrozole – a hormone therapy tablet that reduces estrogen production in the body

Patients in the trial are randomly assigned to one of two groups. One group receives chemotherapy infusions (paclitaxel and carboplatin) followed by daily letrozole tablets, while the other group takes only letrozole tablets.

Who can participate: The trial is open to women aged 18 or older who have newly diagnosed stage II-IV low-grade serous ovarian or peritoneal cancer confirmed by a pathology report. Participants must have undergone surgery to remove as much of the tumor as possible within 8 weeks before starting the study, including removal of both ovaries and fallopian tubes. Women must have adequate organ function, including normal bone marrow, kidney, and liver function. They must also have normal p53 protein expression shown by tissue testing and be able to take oral medications. Participants need to have acceptable physical function, meaning they can care for themselves and be up and about more than 50% of their waking hours.

Who cannot participate: The trial excludes women who have received previous chemotherapy for ovarian or peritoneal cancer, those who have had other types of cancer in the past 5 years (except successfully treated non-melanoma skin cancer or early-stage cervical cancer), and those with serious heart conditions including uncontrolled high blood pressure or heart failure. Women who are pregnant or breastfeeding cannot participate. Other exclusion criteria include active or untreated infections, known allergies to the study medications, inability to take oral medications, major surgery within 4 weeks before the study, serious mental health conditions that could interfere with following study procedures, or participation in another clinical trial within 30 days.

What happens during the trial: After confirming eligibility through medical tests including blood work and imaging scans, participants are randomly assigned to one of the two treatment groups. Those in the combination therapy group receive intravenous medications at the hospital followed by daily letrozole tablets at home. Those in the single therapy group take only daily letrozole tablets at home. Regular check-ups monitor treatment response and any side effects. The follow-up period includes regular medical examinations and imaging scans to assess how well the treatment is working. The study will continue until 2028 or until specific study goals are met.