NUVOLA TRIAL Open-label Multicentre Study
High Grade Serous Ovarian CancerAround 15-25% of ovarian cancer (OC) patients carry germ-line mutation in BRCA1 or BRCA2 genes. Recent evidences showed that OC women with germline BRCA1/2 mutations (gBRCAmut) have an improved survival and higher platinum-sensitivity compared to BRCA1/2 naive (BRCAwt). Interestingly, disease appearance in BRCAmut women is more diffuse than in BRCAwt cases, with significantly higher peritoneal tumour load. Nonetheless, BRCAmut women additionally show a higher benefit of platinum-based neoadjuvant chemotherapy (NACT) plus interval debulking surgery compared with BRCAwt women in terms of clinical and pathological responses, suggesting that BRCA mutational status might be used as a molecular tool to personalize treatment in high-grade serous ovarian cancer (HGSOC) patients. OLAPARIB in BRCA mutation carriers Olaparib is a potent oral poly (ADP-ribose) polymerase (PARP) inhibitor that causes synthetic lethality in BRCA1/2-deficient tumour cells. In patients with platinum-sensitive relapsed serous ovarian cancer, olaparib maintenance treatment significantly improved the duration of progression-free survival compared with placebo (hazard ratio [HR] 0.35 [95% CI (confidence interval) 0.25-0.49]; p<0.0001), with the greatest clinical benefit in patients with BRCA mutations (HR 0.18 [95% CI 0.10-0.31]; p<0.0001). Preclinical data suggest that olaparib might also potentiate the efficacy of DNA-damaging chemotherapies, including platinum-containing drugs such as carboplatin. In a recent phase Ib/II study, olaparib plus weekly carboplatin and paclitaxel in relapsed ovarian cancer patients was shown to be safe, well tolerated and effective, especially in germline BRCA mutated (gBRCAmut) patients. Possibly, the addition of a PARP inhibitor (olaparib) to NACT in HGSOC patient with germline or somatic BRCA1/2 mutation is able to increase the pathological complete response rate to conventional chemotherapy. Combination of intermittent olaparib with weekly carboplatin and paclitaxel might achieve a higher pathological response rate, with an acceptable toxicity profile.
Characterization of Ovarian Cancer Stem Cell
Ovarian CancerSpecific aims: Identification and characterization of cancer stem cell-like population (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood of ovarian cancer patients and genetically engineered mouse ovarian cancer cell lines. Objectives: In the future, individualized therapy must incorporate analysis of the cancer stem cells or cancer initiating cells of ovarian cancer cells when designing therapeutic strategies for ovarian cancer patients. Aims of this project: Isolation and identification of cancer stem cell-like population (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood of ovarian cancer patients In vivo tumorigenicity assay will be performed to measure tumor formation from these cancer stem cell-like population when equal numbers were injected into the dorsal fat pad of nude mice. To establish a standard protocol of stem cell-like population maintenance Screening of potential specific biomarkers involved in these ovarian cancer stem cell-like population.
Cancer Prevention in Women With a BRCA Mutation
BRCA1 Gene MutationBRCA2 Gene Mutation2 moreThis study aims to develop a follow-up telephone-based genetic counselling (FTGC) intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in the past. Typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. If a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. However, in Canada, there is currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing guidance and support about latest risk reduction strategies. Standard care relies on women making contact for any follow-up questions or concerns they may have. As a result, these women might not have the most current information regarding genetic risk assessment and prevention options. Therefore, individuals are being asked to participate in this study to aid research about the efficacy of FTGC in women with a BRCA mutation.
Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer
Ovarian Cancer RecurrentThis is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.
Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial...
Ovarian CancerChemotherapy3 moreOvarian cancer is frequently diagnosed in older women, with over half of all new diagnoses being in women over 65 years. Current treatment options are based on the results of clinical trials that often do not include older, less fit patients in whom treatments may be less well tolerated. Further, in older patients the impact of complex medical and social issues is not known. The UK lags behind Europe and the United States in the development of research programs dedicated to improving outcomes for older patients. More research focus is urgently required to improve the assessment and management of older women with ovarian cancer to improve survival outcomes, quality of life and functional independence. Current treatment decisions are made predominantly on age and fitness. However, it has been shown that undertaking a holistic, geriatric assessment of older patients can highlight important issues that would not necessarily be identified in a routine oncology appointment. In this study, we propose to ask oncology teams to undertake a geriatric assessment and specifically address issues that may arise as a result of this. The assessment comprises 8 simple non-invasive assessments that can be performed in the out-patient setting. This approach could result in an important change in clinical practice leading to more holistic assessment of older cancer patients and better address their specific needs and manage their cancer treatment. The long-term goal is to show that pro-actively managing potential issues at the beginning of treatment allows patients to tolerate treatment and maintain their functional independence, leading to improved quality of life.
Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
Ovarian CancerIn patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy. The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated. The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.
Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Ovarian CancerPrimary objective: To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer. Secondary objectives: To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer To estimate the progression free survival (PFS) and overall survival (OS) for women with recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly docetaxel and weekly topotecan.
CA-125 in Screening Patients at High Risk for Ovarian Cancer
Ovarian CancerRATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment. PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.
Cost Utility Analysis in Recurrent Ovarian Cancer
Ovarian CancerThe goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease. Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment. In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in...
Endometrial CarcinomaStage 0 Fallopian Tube Cancer AJCC v754 moreThis pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.