#1 Clinical Trials Search in Europe

Ovarian cancer stage III – Trials in Disease

Go back

Ongoing Clinical Trials for Ovarian Cancer Stage III

There are currently 6 clinical trials investigating new treatment approaches for Stage III ovarian cancer across Europe. These studies are exploring various treatment combinations including chemotherapy modifications, immunotherapy, hormonal therapy, and heated intraperitoneal chemotherapy delivery methods. Trials are taking place in multiple European countries including the Netherlands, France, Italy, Germany, Belgium, Spain, and several others.

Clinical trial locations

Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer

This trial is testing a modified chemotherapy schedule for patients whose cancer has not responded well to initial treatment and could not be completely removed by surgery. The study compares standard chemotherapy given every three weeks with a weekly dose-dense regimen that involves smaller, more frequent doses.

Main inclusion criteria: Participants must be women aged 18 or older with high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer at stage III or IV. They should have received 3 to 4 cycles of standard carboplatin-paclitaxel chemotherapy with poor response, shown by an unfavorable KELIM score of less than 1.0. This score measures how well the cancer responds to chemotherapy. Patients must have adequate organ function, including sufficient blood cell counts, and normal kidney and liver function. They must also have an ECOG performance status of 0 or 1, meaning they can perform daily activities with minimal or no restrictions.

Main exclusion criteria: Patients whose cancer can be completely removed by surgery, those who are male, or those outside the specified age range cannot participate. Additionally, vulnerable populations requiring special protection are excluded.

Trial focus: The study aims to determine whether the weekly dose-dense chemotherapy regimen can improve outcomes such as successful surgery rates and survival times compared to standard treatment. The trial will monitor overall response to treatment, progression-free survival, quality of life, and any side effects experienced by participants over a treatment period of up to 64 weeks.

Investigational drugs: The trial uses carboplatin and paclitaxel, both established chemotherapy medications. Carboplatin works by interfering with cancer cell DNA, preventing growth and division, while paclitaxel inhibits cell division by stabilizing cell structures. The study also involves bevacizumab, which prevents blood vessel growth to tumors, and filgrastim, which boosts white blood cell counts during chemotherapy.

Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

This study investigates whether maintenance therapy with niraparib after three cycles of chemotherapy is as effective as after six cycles for patients who have no remaining tumor after surgery.

Main inclusion criteria: Participants must be women aged 18 or older who are postmenopausal or unable to have children. They must have advanced high-grade ovarian cancer at stage III or IV, with tumor samples confirming HRD positive genetic status. Complete tumor removal must be confirmed by CT scan. Patients must have good general health with an ECOG performance status of 0 or 1, be able to take oral medications, and have adequate organ and bone marrow function, including hemoglobin levels of at least 10.0 g/dL, specific white blood cell counts, platelet counts above 100 x 10⁹/L, and normal liver and kidney function.

Main exclusion criteria: Male patients, those with remaining tumor mass after surgery, patients who have not undergone surgery to remove the primary tumor, and those not diagnosed with the specific cancer types mentioned in the study cannot participate. Vulnerable populations are also excluded.

Trial focus: The trial will evaluate whether shorter treatment duration with niraparib can provide similar benefits in preventing cancer recurrence. Participants will undergo initial chemotherapy cycles followed by maintenance therapy with niraparib. The study will assess recurrence-free survival, overall survival, and monitor patients for side effects through regular health evaluations until 2032.

Investigational drugs: Niraparib is a PARP inhibitor taken orally as a capsule. It works by blocking an enzyme involved in DNA repair, which prevents cancer cells from repairing their DNA and leads to their death. The trial also uses standard chemotherapy agents carboplatin and paclitaxel administered intravenously.

Study on the Effect of Hyperthermic Intraperitoneal Chemotherapy with Cisplatin for Stage III Ovarian Cancer Patients Undergoing Surgery

This trial examines whether adding heated chemotherapy directly into the abdominal cavity during surgery improves survival compared to surgery alone for stage III epithelial ovarian cancer patients.

Main inclusion criteria: Participants must be women at least 18 years old with confirmed FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer. Surgery must have removed the cancer leaving no more than 2.5 mm behind. Patients must be fit for major surgery with a WHO performance status of 0-2, meaning they can perform daily activities with some limitations at most. Adequate bone marrow function is required, with hemoglobin above 5.5 mmol/L, specific white blood cell and platelet counts. Liver function must show ALT, AST, and bilirubin levels less than 2.5 times the normal upper limit, and kidney function must demonstrate creatinine clearance of at least 60 ml/min.

Main exclusion criteria: Male patients and those who do not have FIGO stage III ovarian cancer cannot participate. Patients not eligible for primary cytoreductive surgery or those with residual disease larger than 2.5 mm after surgery are excluded, as are vulnerable populations.

Trial focus: The study evaluates whether combining surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) provides better outcomes for patients. HIPEC involves delivering heated cisplatin directly into the abdominal cavity to kill remaining cancer cells. The trial monitors overall survival, recurrence-free survival, and time to requiring further cancer treatment, along with side effects experienced during treatment.

Investigational drugs: The trial uses cisplatin administered both intravenously and intraperitoneally as heated chemotherapy. Additional medications include paclitaxel, sodium thiosulfate to reduce side effects, bevacizumab to prevent blood vessel growth to tumors, and carboplatin.

Study on Letrozole vs. Chemotherapy (Carboplatin and Paclitaxel) for Patients with Advanced Low-Grade Serous Ovarian Cancer with Hormone Receptors

This trial compares the effectiveness of the hormonal medication letrozole with standard chemotherapy for patients with low-grade serous ovarian cancer that is positive for estrogen and/or progesterone receptors.

Main inclusion criteria: Participants must be women aged 18 or older with newly diagnosed low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum at stage III-IV. The cancer must show at least 10% positivity for estrogen and/or progesterone receptors. Patients must have undergone surgery to remove as much tumor as possible and must join the study within 90 days, preferably within 60 days, after surgery. They must be postmenopausal, either through surgery or naturally, with specific hormone levels confirming this status. An ECOG performance status of 0-1 is required, meaning they can perform daily activities with minimal restrictions. Patients must be able to take oral medications and have adequate bone marrow, liver, and kidney function as demonstrated by specific blood test results.

Main exclusion criteria: Male patients and those whose cancer is not low-grade serous epithelial carcinoma at FIGO stage III-IV cannot participate. Patients whose cancer is not ER+ and/or PgR+ are excluded, as are those who have not had primary surgery.

Trial focus: The study aims to determine if letrozole, which works by reducing estrogen levels in the body, can provide a longer period without cancer progression compared to standard chemotherapy with carboplatin and paclitaxel. Participants will be randomly assigned to receive either letrozole or chemotherapy and will undergo regular monitoring to track cancer progression and overall health.

Investigational drugs: Letrozole is an aromatase inhibitor taken orally as a film-coated tablet at a typical dosage of 2.5 mg once daily. It works by blocking the enzyme aromatase, which produces estrogen, thereby reducing estrogen levels and slowing the growth of estrogen-dependent cancer cells. The trial also uses standard chemotherapy agents carboplatin and paclitaxel for comparison.

Study of Niraparib and Dostarlimab Combined with Platinum Therapy for Newly Diagnosed Stage III or IV Non-mucinous Epithelial Ovarian Cancer

This study evaluates whether combining two newer medications, niraparib and dostarlimab, with standard platinum-based chemotherapy improves outcomes compared to using niraparib alone with chemotherapy.

Main inclusion criteria: Participants must be women aged 18 or older diagnosed with Stage III or IV non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer. They must have adequate physical performance status with an ECOG score of 0 or 1, meaning they can perform daily activities with minimal limitations. Blood pressure must be normal or controlled, not exceeding 140/90 mmHg. Patients must be able to take oral medications and provide blood and tumor tissue samples for testing. Adequate organ function is required, including sufficient blood cell counts and normal kidney and liver function. Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 180 days after treatment. Patients must be willing to complete quality of life questionnaires throughout the study.

Main exclusion criteria: Male patients, those under 18 years old, and patients with mucinous ovarian cancer cannot participate. Those who have previously been treated with dostarlimab or niraparib or have known allergies to these medications are excluded. Patients with cancer stages other than III or IV, those with other active cancers requiring treatment, severe heart conditions, uncontrolled high blood pressure, significant liver or kidney problems, or who are pregnant or breastfeeding cannot participate. Those participating in other clinical trials within the past 30 days or with mental conditions interfering with study procedures are also excluded.

Trial focus: The study aims to determine if adding dostarlimab, an immunotherapy medication that helps the immune system fight cancer cells, to the combination of niraparib and platinum-based chemotherapy can extend the time patients live without cancer progression. Participants will receive treatment for up to 72 months with regular medical check-ups to monitor effectiveness and side effects.

Investigational drugs: Dostarlimab is an immunotherapy drug given through intravenous infusion. It is an anti-PD-1 monoclonal antibody that helps the immune system recognize and attack cancer cells by blocking a protein that cancer cells use to hide. Niraparib is a PARP inhibitor taken orally as capsules once daily, working by preventing cancer cells from repairing their DNA. The trial also uses standard platinum-based chemotherapy.

Study on Dosing Methods of Cisplatin for Women with Advanced Ovarian Cancer

This trial compares two different methods of calculating cisplatin doses for heated chemotherapy delivered directly into the abdominal cavity during surgery: one based on body surface area and one based on drug concentration.

Main inclusion criteria: Participants must be women at least 18 years old with confirmed FIGO stage III high-grade serous ovarian, peritoneal, or fallopian tube cancer. They must have received at least three courses of chemotherapy with carboplatin and paclitaxel before surgery, without cancer progression after two cycles. Patients must be eligible for interval cytoreductive surgery with OVHIPEC, where the cancer can be surgically removed successfully. Adequate kidney function with creatinine clearance of at least 60 ml/min is required, along with fitness for major surgery demonstrated by WHO performance status of 0-2. Adequate bone marrow function is needed, including hemoglobin above 5.5 mmol/L and specific white blood cell and platelet counts. Liver function must show ALT, AST, and bilirubin levels less than 2.5 times normal. Peritoneal disease must be present at surgery, and the procedure must achieve optimal or complete tumor removal.

Main exclusion criteria: Male patients and those who do not have FIGO stage III high-grade serous ovarian, peritoneal, or fallopian tube carcinoma cannot participate. Vulnerable populations are also excluded.

Trial focus: The study evaluates which cisplatin dosing method is more effective for treating advanced ovarian cancer through hyperthermic intraperitoneal chemotherapy. Researchers will monitor cisplatin concentration in tumor and normal tissues, assess treatment safety and side effects, and track recurrence-free survival and overall survival. The trial aims to provide insights into the most effective dosing strategy for improving treatment outcomes.

Investigational drugs: Cisplatin is a platinum-based chemotherapy drug administered as a solution directly into the abdominal cavity during surgery as part of hyperthermic intraperitoneal chemotherapy (HIPEC). It works by binding to DNA and interfering with cancer cells’ ability to divide and grow, ultimately leading to their death.

Summary

The six ongoing clinical trials for Stage III ovarian cancer demonstrate diverse approaches to improving treatment outcomes. Several trials focus on optimizing existing chemotherapy schedules and delivery methods, while others investigate combining newer targeted therapies and immunotherapy with standard treatments.

Geographically, these trials show significant concentration in Western European countries, particularly in the Netherlands, Italy, France, and Germany. Italy participates in five of the six studies, while the Netherlands participates in four. This distribution reflects the strong research infrastructure and collaborative networks in these regions for gynecological cancer research.

Several medications appear across multiple trials. Niraparib, a PARP inhibitor, is investigated in two studies examining its role as maintenance therapy. Carboplatin and paclitaxel, standard chemotherapy agents, serve as comparison arms in multiple trials. Three studies explore hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin, representing growing interest in this specialized delivery method for directly targeting abdominal cancer deposits.

The trials address different patient populations based on tumor characteristics. Some focus on poor prognosis patients with chemotherapy-resistant disease, others on patients with complete surgical removal, and one specifically targets low-grade serous tumors with hormone receptors. This variety ensures research covers the spectrum of Stage III presentations and provides treatment options tailored to specific disease characteristics.

Ongoing Clinical Trials on Ovarian cancer stage III

  • Study on Letrozole vs. Chemotherapy (Carboplatin and Paclitaxel) for Patients with Advanced Low-Grade Serous Ovarian Cancer with Hormone Receptors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Italy

  • Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Germany Italy Spain

  • Study on Adjusting Chemotherapy with Carboplatin and Paclitaxel for Patients with Poor Prognostic Ovarian Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy The Netherlands

  • Study on the Effects of Tinzaparin on Biomarkers in Advanced Ovarian Cancer Patients Receiving Chemotherapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study of Niraparib and Dostarlimab Combined with Platinum Therapy for Newly Diagnosed Stage III or IV Non-mucinous Epithelial Ovarian Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +7

  • Study on the Effect of Hyperthermic Intraperitoneal Chemotherapy with Cisplatin for Stage III Ovarian Cancer Patients Undergoing Surgery

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Ireland Italy The Netherlands +1

More information about
Ovarian cancer stage III:

Connected medications: