Ongoing Clinical Trials for Fallopian Tube Cancer Stage IV
There are currently 2 clinical trials investigating new treatment approaches for Stage IV fallopian tube cancer. These studies are testing combinations of chemotherapy drugs and targeted therapies to improve outcomes for patients with advanced disease. Trials are being conducted across several European countries including Germany, Spain, France, Italy, Belgium, the Netherlands, Austria, and Czechia.
Clinical trial locations
- Austria
- Belgium
- Czechia
- France
- Germany
- Italy
- Netherlands
- Spain
Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer
This trial focuses on patients with advanced cancer who have a poor prognosis because their disease does not respond well to initial chemotherapy and cannot be completely removed through surgery. The study is testing whether giving chemotherapy more frequently in smaller doses, known as a weekly dose-dense regimen, works better than the standard schedule of larger doses every three weeks.
Main inclusion criteria: Patients must be adults aged 18 or older with confirmed high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer at stage III or IV. They must have already received 3 to 4 cycles of standard carboplatin-paclitaxel chemotherapy with a poor response, shown by an unfavorable KELIM score of less than 1.0. This score measures how well the cancer responds to treatment. Patients need to have good organ and bone marrow function, adequate kidney and liver function, and be able to perform daily activities with little restriction, measured by an ECOG performance status of 0 or 1.
Main exclusion criteria: The trial excludes male patients, as only female patients are eligible. Patients whose cancer can be completely removed by surgery or who have a favorable response to initial treatment are not eligible. Additionally, patients belonging to vulnerable populations requiring special protection are excluded.
Focus and goals: The trial aims to determine whether the weekly dose-dense chemotherapy regimen can improve outcomes such as increasing the chances of successful surgery and extending survival times. The study will monitor overall response to treatment, progression-free survival, overall survival, and quality of life. Treatment will be given over a period of up to 64 weeks, with the trial expected to conclude by the end of 2028.
Investigational drugs: The trial uses carboplatin and paclitaxel, both chemotherapy medications. Carboplatin works by interfering with the DNA of cancer cells to prevent them from growing and dividing. Paclitaxel helps stop cancer cell growth by preventing them from dividing. The study also involves bevacizumab, which prevents the growth of blood vessels that supply the tumor, and filgrastim, which helps boost white blood cell counts during chemotherapy.
Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal
This study is investigating treatment for advanced high-grade cancer in patients who have no remaining tumor after initial surgery. The trial is testing whether maintenance treatment with niraparib after three cycles of chemotherapy is as effective as taking it after six cycles.
Main inclusion criteria: Participants must be women aged 18 or older who are either postmenopausal or not able to have children. They must have advanced high-grade ovarian, fallopian tube, or primary peritoneal cancer at stage III or IV, but not the mucinous type. Patients must have undergone surgery to remove the primary tumor with no visible tumor remaining on CT scan. Tumor samples must be available to confirm a specific genetic status called HRD positive. Patients need good general health with an ECOG performance status of 0 or 1, be able to take oral medications, and have normally functioning organs and bone marrow.
Main exclusion criteria: The trial excludes patients who have not had surgery to remove the primary tumor or who have remaining tumor mass after surgery. Male patients are not eligible, and patients from vulnerable populations are excluded. Patients with types of cancer not specified in the study are also excluded.
Focus and goals: The study aims to determine if a shorter treatment duration with niraparib can provide similar benefits in preventing cancer from returning. Researchers will monitor how long patients live without the cancer coming back and their overall survival rates. Regular assessments will be conducted to monitor recurrence-free survival and overall health throughout the trial, which is expected to continue until March 31, 2032.
Investigational drugs: The trial uses niraparib as a maintenance therapy, given as oral tablets after initial chemotherapy with carboplatin and paclitaxel. Niraparib works by inhibiting an enzyme called PARP, which is involved in DNA repair. By blocking this enzyme, niraparib prevents cancer cells from repairing their DNA, leading to cancer cell death. This approach helps extend the time patients remain free from cancer recurrence.
Summary
Currently, two clinical trials are available for patients with Stage IV fallopian tube cancer across multiple European countries. Both studies focus on optimizing chemotherapy approaches using carboplatin and paclitaxel as foundational treatments. The first trial investigates more intensive dosing schedules for patients with poor initial response to treatment, while the second explores maintenance therapy with niraparib for patients who have achieved complete tumor removal through surgery.
These trials represent different treatment scenarios: one for patients with chemotherapy-resistant disease who cannot undergo complete surgical removal, and another for patients who have successfully undergone surgery and have specific genetic markers. Italy offers access to both trials, providing options for patients in different clinical situations. Both studies emphasize personalized approaches based on treatment response and genetic factors, reflecting modern precision medicine strategies for advanced gynecological cancers.
