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Carcinoma, Ovarian Epithelial clinical trials

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NCT ID: NCT04878094 Recruiting - Ovarian Cancer Clinical Trials

A Study of Intra-operative Imaging in Women With Ovarian Cancer

Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.

NCT ID: NCT04864431 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer

VitD
Start date: January 12, 2022
Phase: N/A
Study type: Interventional

Several ex vivo, in vitro, and observational studies on various type of cancer shown positive effect of vitamin D. Vitamin D has widely known as immunomodulator property in various diseases. However, it remains limited studies on immunity and cachexia in cancer, particularly in ovarian cancer. This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia

NCT ID: NCT04862325 Recruiting - Clinical trials for Advanced Ovarian Cancer

SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

SOPHIE
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.

NCT ID: NCT04861181 Recruiting - Clinical trials for Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer

NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.

NIRAPK
Start date: May 5, 2021
Phase: Phase 4
Study type: Interventional

Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries. Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor. A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy. There is however a high rate of relapse/recurrence (disease progression ranging from 10 to 26 months). Poly ADP ribose polymerase inhibitors (PARPi), a new class of therapeutic molecules have recently revolutionized this paradigm, demonstrating progression-free survival (PFS) advantages in several trials. The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line, irrespectively of patients' BRCA-mutated gene or HR status. Since, results of the Phase III trial PRIMA, have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment, for adult patients with platinum-sensitive, relapsed, high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy, irrespectively of their BRCA-mutated gene or HR status. However, despite its high therapeutic potential, Niraparib at standard dose (200 or 300mg/day) is known to lead to hematologic toxicity and/or nephrotoxicity. This was demonstrated during the NOVA trial (the dose of Niraparib having to be reduced in 80% of the patients to reduce toxicity). A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight <77kg and an initial platelet count <175 G/L. However, it seems more complex as 50% of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia. Same for platelet count. Creatinine clearance below 60ml/min and an hypoalbuminemia <35 g/l have also been identified in another study as predictive factors to thrombocytopenia. The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood. The aim of our study is therefore to better identify which clinical, biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment (200 or 300mg/day) for ovarian cancer patients.

NCT ID: NCT04846842 Not yet recruiting - Clinical trials for Fallopian Tube Cancer

A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.

NCT ID: NCT04840589 Recruiting - Clinical trials for Metastatic Malignant Solid Neoplasm

Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors

Start date: February 2, 2022
Phase: Phase 1
Study type: Interventional

This phase I/Ib trial is to find out the best dose, possible benefits and/or side effects of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when given in combination with nivolumab with or without ipilimumab in treating patients with solid tumors. ZEN003694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ZEN003694 in combination with nivolumab with or without ipilimumab may shrink or stabilize solid tumors.

NCT ID: NCT04834544 Recruiting - Clinical trials for Primary Peritoneal Carcinoma

A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care

Start date: April 19, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.

NCT ID: NCT04830709 Recruiting - Ovarian Cancer Clinical Trials

Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer

SCOUT-1
Start date: June 15, 2021
Phase:
Study type: Observational

This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: - outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, - patient's follow-up (FU) during and after MTX therapy, - patient-reported outcomes (PROs), experiences and needs, - physician's experience, - BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, - patient selection for different 1L systemic treatment approaches, - use and safety of drugs, - treatment sequence in case of recurrence

NCT ID: NCT04828616 Not yet recruiting - Ovarian Cancer Clinical Trials

Study of DP303c Injection in Patients With Advanced Ovarian Cancer

Start date: July 2021
Phase: Phase 2
Study type: Interventional

This study is an open-label, multicentre, phase II study to evaluate the efficacy and safety of of DP303c injection in patients with HER2-expressing advanced ovarian cancer.

NCT ID: NCT04826198 Recruiting - Ovarian Cancer Clinical Trials

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

REVOCAN
Start date: October 5, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of REVOCAN study is to assess the abrogation of PARP inhibitors resistance in patients with relapsed platinum sensitive ovarian cancer treated with PARP inhibitors in maintenance since at least 6 months and who have only an increase of CA 125 without any progression according to RECIST criteria. AsiDNATM at 600 mg will be tested in addition to PARP inhibitors given according to the label in REVOCAN study.