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Ovarian Neoplasms clinical trials

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NCT ID: NCT05444270 Recruiting - Clinical trials for Recurrent Epithelial Ovarian Cancer

Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer

SABR-ROC
Start date: October 26, 2022
Phase: N/A
Study type: Interventional

Rationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy. In the 1980~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, provided chemotherapy holiday in selected cases, but did not prevent out-field progression. Stereotactic ABlative Radiotherapy (SABR) is the latest treatment using an intensity modulated technique to increase the fractional dose, reduces the number of treatments, and destroys the tumor with high accuracy. SABR-COMET study, a representative clinical study, showed a significant increase in overall survival in solid cancers. Objectives The primary objective; to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer. The secondary objectives; - to check whether it significantly affects quality of life (Health-related QoL), patient-reported outcome (PRO) - to develop an deep learning-based predictive model for the treatment response of ovarian cancer subjects using radiomic and genomic analysis. Study design Arm 1; Standard salvage therapy Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. Arm 2; Standard salvage therapy+ SABR Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. Stratification factors 1. The number of No ascites, Platinum-sensitive, Normal CA125 and ECOG0-1; 0~3 vs. 4 2. Location of the lesion; Lymph node lesion vs. Non-lymph node lesion 3. PARP inhibitor; Used vs. Not used Randomization Arm 1 : Arm 2 = 1 : 2 Estimated Accrual : - The sample size 270 was calculated by setting the sample size to a Type I error rate (α) of 0.05 and Statistical Power of 80% using 2-Sided Equity and log-rank test. - Accurate time: 2 years, Follow-up: 3 years (total 5 years) - Alpha = 0.05, Power = 80% - 1 year drop-out: 5% per group - 3 year survival proportion: RT group 74.42%, No RT group 58% - Arm 1: Arm 2 = 1 : 2 ratio

NCT ID: NCT05440578 Not yet recruiting - Ovarian Neoplasms Clinical Trials

First-line Olaparib Combined With Bevacizumab Maintenance Therapy

Start date: June 2022
Phase:
Study type: Observational

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION( NMPA) -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.

NCT ID: NCT05431530 Recruiting - Quality of Life Clinical Trials

Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

LAPSODY
Start date: June 22, 2022
Phase:
Study type: Observational

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

NCT ID: NCT05430906 Recruiting - Ovarian Cancer Clinical Trials

AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Start date: November 25, 2022
Phase: Phase 2
Study type: Interventional

Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile. AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.

NCT ID: NCT05429970 Recruiting - Ovarian Cancer Clinical Trials

A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

Start date: June 17, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

NCT ID: NCT05422183 Not yet recruiting - Clinical trials for Ovarian Cancer, Epithelial

Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib VP-16 in the treatment of platinum-resistant recurrent epithelial ovarian cancer,primary fallopian tube cancer and primary peritoneal carcinoma.

NCT ID: NCT05415709 Recruiting - Clinical trials for Ovarian Endometrioid Adenocarcinoma

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer

Start date: June 13, 2022
Phase: Early Phase 1
Study type: Interventional

This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.

NCT ID: NCT05415527 Recruiting - Ovarian Carcinoma Clinical Trials

Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management

OPTIMOVA
Start date: June 11, 2022
Phase: N/A
Study type: Interventional

Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

NCT ID: NCT05410938 Completed - Clinical trials for Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer

Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy

Start date: June 6, 2022
Phase:
Study type: Observational

The combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the NCCN Guidelines for Epithelial Ovarian Cancer, and is conventionally given via intravenous route every three weeks. The addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. Several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. This study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

NCT ID: NCT05410028 Recruiting - Ovarian Cancer Clinical Trials

New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence

Start date: March 3, 2022
Phase:
Study type: Observational

In this study, mass spectrometry was used to analyze immune inflammation-related protein complexes, post-translational modified glycopeptide omics and tumor-related metabolomics in serum, respectively, in order to find potential metabolic small molecule biomarkers or marker profiles that can be used for early diagnosis of cancer recurrence.