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Vulvar Neoplasms clinical trials

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NCT ID: NCT06023862 Recruiting - Ovarian Neoplasms Clinical Trials

A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

DOVE
Start date: January 22, 2024
Phase: Phase 2
Study type: Interventional

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Group A: Dostarlimab monotherapy - First 3 cycles: Dostalimab 500mg every 3 weeks, IV - 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV 2. Group B: Dostarlimab + Bevacizumab combination therapy - First 3 cycles: Dostalimab 500mg every 3 weeks, IV - 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV - Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

NCT ID: NCT05979610 Recruiting - Cervical Cancer Clinical Trials

Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

Reiki-Brachy
Start date: October 9, 2023
Phase: Phase 2
Study type: Interventional

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

NCT ID: NCT05952947 Recruiting - Cervical Cancer Clinical Trials

HRYZ-T101 Injection for HPV18 Positive Solid Tumor

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

A multicenter, open label, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 injection for HPV18 positive solid tumor. The study will investigate RP2D of HRYZ-T101 TCR-T cell injection.

NCT ID: NCT05934851 Recruiting - Vulvar Neoplasm Clinical Trials

A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

Start date: November 7, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.

NCT ID: NCT05916690 Recruiting - Vulvar Cancer Clinical Trials

Electrochemotherapy for the Treatment of Vulvar Cancer

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

Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.

NCT ID: NCT05914974 Recruiting - Ovarian Cancer Clinical Trials

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Start date: September 11, 2023
Phase:
Study type: Observational

ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).

NCT ID: NCT05905315 Recruiting - Clinical trials for Squamous Cell Carcinoma of the Vulva

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

VULCANIZE-II
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.

NCT ID: NCT05787535 Recruiting - Cervical Cancer Clinical Trials

HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor. The study will investigate DLT of HRYZ-T101 TCR-T cell injection.

NCT ID: NCT05786456 Recruiting - Clinical trials for Malignant Female Reproductive System Neoplasm

e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

This clinical trial studies how well an electronic (e)-health intervention (day-by-day) woks in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic cancer. Fear and worries about cancer progression or recurrence (coming back) are common concerns. This may contribute to concerns related to illness, worries, and uncertainty about the future. Day by Day is adapted from a program called "Conquer Fear" which was shown to benefit patients with early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help patients learn skills to manage anxiety and fears.

NCT ID: NCT05743517 Recruiting - Cervical Cancer Clinical Trials

Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.