ANZGOG GYNAECOLOGICAL CLINICAL TRIALS
Are you participating in an ANZGOG clinical trial? We are in regular contact with our clinical members at trial sites to ensure they are briefed about preferred treatment plans to ensure the safety and wellbeing of women taking part in research.
Patients are encouraged to speak with their oncologist regarding their concerns including the best ways for their participation or continuance on a clinical trial.
GYNAECOLOGICAL CANCER TRIALS CURRENTLY RECRUITING
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ANVU | NCT06476639
The ANVU trial aims to determine whether groin ultrasound monitoring (1) is effective and safe to replace invasive groin LND to manage vulvar cancer; (2) decreases the morbidity associated with vulvar cancer surgery; and (3) is cost-effective.
Eligibility Criteria
Histologically proven vulvar cancer clinical stages 1b or 2.
DOVE | APGOT-OV7/ENGOT-ov80
The DOVE trial is a Phase II, randomised study evaluating the efficacy and safety of dostarlimab alone or with bevacizumab versus nonplatinum chemotherapy in recurrent gynaecological clear cell carcinoma.
Eligibility Criteria
Histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva, ECOG Performance Status 0 or 1, disease progression within 12 months of completing platinum-based chemotherapy, 1-5 prior lines of therapy, measurable disease according RECIST 1.1 criteria.
Investigator Video >EN.10/TAPER | NCT05640999
The primary objective of this study is to estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status.
Eligibility Criteria
Women with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer.
ENDO-3 | NCT04073706
ENDO-3 is a randomised controlled trial that compares sentinel lymph node dissection, a commonly performed procedure for the surgical staging of endometrial cancer, to no node dissection. The outcomes from this trial will provide high-level evidence on sentinel lymph node dissection’s effectiveness, benefit and harm to patients.
Eligibility Criteria
Women with histologically confirmed endometrial cancer; clinical stage 1, who meet the criteria for laparoscopic or robotic total hysterectomy and bilateral salpingo-oophorectomy. If participants (≤45 years of age) wish to retain their ovaries, a BSO may be omitted.
PEACE | ACTRN12621001031853
PEACE aims to determine the feasibility of collecting information from women, and their careers, with advanced gynaecological cancer about their experiences, satisfaction with care and symptom management towards end of life. Information collected focuses on how both patients and their careers are feeling about the palliative care process and the care they are receiving.
Eligibility Criteria
Women aged 18 years or over with advanced gynaecological malignancy and a life expectancy of approximately 4 months. Able to complete questionnaires independently.
RAMP-301 | NCT06072781
The RAMP-301 trial will assess the safety and efficacy of the combination of Avutometinib plus Defactinib versus Investigator’s Choice of Treatment options (ICT) in patients with recurrent Low-grade Serous Ovarian Cancer (LGSOC) who have progressed on a prior platinum-based therapy.
Eligibility Criteria
Women with recurrent, platinum-resistant, low-grade serous ovarian cancer (ovarian, fallopian, peritoneal).
REZOLV3R | ACTRN12624000288527
The REZOLV3R trial compares post treatment paracentesis free survival time between each treatment group (bevacizumab or control). The aim is to improve quality of life and optimise management of patients with advanced cancers with recurrent malignant ascites in the final months of life.
Eligibility Criteria
Symptomatic, cytologically confirmed malignant ascites arising from a solid organ malignancy.
STRIVE/VU.2 | NCT06358469
Primary Objective - To estimate the 3-year local recurrence rates in patients with HPV-A and HPV-I VSCC surgically managed based on dVIN/p53 status and tumour margin clearance.
Eligibility Criteria
Women with primary vulvar squamous cell carcinoma (VSCC), FIGO stage 1-11.
XPORT-EC-042
XPORT aims to evaluate the benefit of selinexor in patients with no TP53 alteration advanced or recurrent Endometrial Cancer. Patients will receive either oral selinexor or placebo as maintenance therapy following chemotherapy, until disease progression.
Eligibility Criteria
Women with TP53 wild-type advanced or recurrent Endometrial Cancer who have completed at least 12 weeks of platinum-based therapy with or without immunotherapy and achieved confirmed partial or complete response.
Investigator Video >
