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Ovarian Neoplasms clinical trials

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NCT ID: NCT04534075 Recruiting - Gynecologic Cancer Clinical Trials

Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

FIDURA
Start date: September 2, 2020
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.

NCT ID: NCT04533763 Recruiting - Ovarian Cancer Clinical Trials

Living WELL: A Web-Based Program for Ovarian Cancer Survivors

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of a group-based and web-delivered psychosocial intervention for ovarian cancer survivors (Mindful Living [ML]) compared to a health promotion condition (Healthy Lifestyles [HL]) in increasing health related quality of life (HRQOL) and decreasing perceived stress, depressive mood (primary aims), anxiety, and fatigue (secondary aims) across a 12-month period.

NCT ID: NCT04523116 Recruiting - Ovary Cancer Clinical Trials

Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: VALTIVE1

VALTIVE1
Start date: January 14, 2021
Phase:
Study type: Observational

Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer through blood vessels to other organs (metastasis). The formation of new blood vessels is known as angiogenesis, which is controlled by a growth factor (like a hormone) called Vascular Endothelial Growth Factor (VEGF). Many drugs have been developed that block VEGF and, in most tumour types, including ovarian cancer, the addition of VEGF inhibitors (VEGFi) to conventional anti-cancer therapy postpones recurrence of the disease. In ovarian cancer, VEGFi improve the overall outcome from the cancer in patients who have advanced stage and high-risk disease. VEGFi are now widely used in cancer medicine, yet until now there have not been any biomarkers (tests) that could be used to tell patients and their doctors whether the drugs were working or not. This is important, as VEGFi have side effects that are unpleasant for the patient. Additionally, VEGFi treatments are expensive. The VALTIVE team has discovered the first biomarker that informs doctors whether a VEGFi is blocking a tumour's blood supply. The test involves measuring a protein in the blood called Tie2, which can be measured from routine blood tests that patients have when going to the hospital. If the test shows that the amount of Tie2 decreases in the blood, it means that tumour blood vessels are blocked by VEGFi; if, on the contrary, the level increases, the blood vessels have escaped the control of VEGFi. The investigators have shown that the Tie2 test works in their initial studies in ovarian and bowel cancer. In these studies, the Tie2 blood test was based in the research laboratories. The investigators now wish to establish the test in the Christie Hospital NHS Biochemistry laboratory in Manchester so that it can be used in clinical practice rather than just as a research tool. The investigators wish to measure the relationship between loss of control of VEGF inhibitors as measured by TIE 2 and other standard ways of measuring loss of control of the tumour like increases on CT scans. There are several reasons why this test is needed for patients with ovarian cancer: - VEGFi are effective during a patient's first or subsequent treatments for advanced ovarian cancer, but it is not clear which individuals are benefitting from treatment whilst they are on treatment. - Patients who have already had one course of VEGFi can be re-treated successfully. - Patients can avoid needless side effects, if there is a way of demonstrating that the treatment is of no benefit to them. - This test will help doctors choose the best drug to control ovarian cancer and how long to continue treatment. This is very important, since other maintenance therapies are now available and the optimal duration of VEGFi therapy is well known. - Around the world many teams are developing new combination treatments including VEGFi. If these new combinations prove effective, it would be possible to use them as efficiently as possible, as they will be very expensive and may therefore be less accessible to patients. These issues highlight the critical need to establish a test in the NHS that tells patients and their doctors when VEGFi are working and when they stop working. In VALTIVE1 study, blood samples will be taken from patients who are receiving a VEGFi called bevacizumab for ovarian cancer. Patients' management will not change during their participation to the trial. The analysis of the blood sample will support the hypothesis that patients whose Tie2 level decreases in response to bevacizumab will have ovarian cancer that is controlled for much longer than those where the Tie2 level does not decrease. These results will be used to design a second trial where the investigators will prove conclusively the value of the Tie2 test. The purpose of VALTIVE1 is to optimise sample acquisition time points and analytical algorithms to support the design of VALTIVE2, a randomised discontinuation trial. In VALTIVE2, Tie2-defined, vascular non-responding patients will be randomly allocated to stop bevacizumab after 9 weeks, by when a response can be detected, or to continue bevacizumab for the conventional year of treatment. Both VALTIVE 1 and VALTIVE2 will test the theory that there is no advantage in continuing bevacizumab in a patient whose Tie2 level does not reduce in response to VEGFi.

NCT ID: NCT04520074 Recruiting - Ovarian Cancer Clinical Trials

Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)

Start date: October 8, 2021
Phase: Phase 3
Study type: Interventional

Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after first line of therapy by optimal cytoreductive sugery and 6cycle of TP chemotherapy. There is no standard maintainance therapy for BRCA1/2 wide-type ovarian cancer. We developed an adjuvant chemotherapy of "three steps" (ACTS). It is adding CTX+VP-16(second step) 6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this study is to verify the effectivity and safety of ACTS in BRCA1/2 wide-type ovarian cancer patients.

NCT ID: NCT04519151 Recruiting - Ovarian Neoplasms Clinical Trials

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

NCT ID: NCT04518501 Recruiting - Efficacy and Safety Clinical Trials

Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes. To explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients.

NCT ID: NCT04517357 Recruiting - Clinical trials for Relapsed Ovarian Cancer

A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

Start date: October 16, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

NCT ID: NCT04516447 Recruiting - Solid Tumor Clinical Trials

A Study of ZN-c3 in Patients With Ovarian Cancer

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

NCT ID: NCT04507841 Recruiting - Ovarian Cancer Clinical Trials

Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation or can not tolerate surgery.

NCT ID: NCT04504110 Recruiting - Clinical trials for Epithelial Ovarian Cancer

68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.