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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ADELE | ACTRN12621000273886
ADELE is a randomised phase 2 trial testing the effect of ADjuvant tislelizumab plus chemotherapy after post-operative pelvic chemoradiation in high risk EndometriaL cancer.
Eligibility Criteria
People with high-risk endometrial cancer (FIGO 2018 stage IA with myometrial invasion-IVA with serious, clear cell or carcinosarcoma histology; FIGO 2018 stage III-IVA with endometroid histology; FIGO 2018 stage II endometrioid histology that is grade 3 or p53 abnormal). Participants must have completed surgery with total hysterectomy and bilateral salpingo-oophorectomy and be planned for adjuvant therapy.
Investigator Video >DOMENICA | NCT05201547
The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated in a first line setting with chemotherapy (paclitaxel and carboplatin) versus dostarlimab.
Eligibility Criteria
Women with MMR deficient advanced or recurrent endometrial cancer.
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.
PARAGON-II | ACTRN12621000639820
PARAGON-II is a trial investigating whether a combination of two drugs (letrozole with alpelisib or letrozole with ribociclib) is an active treatment for a range of advanced gynaecological cancers that expresses hormone receptors.
Eligibility Criteria
Adult, post-menopausal patients with advanced, hormone-receptor positive gynaecological cancers. This includes cancers of the ovaries, fallopian tubes, peritoneum or uterine cancers.
Investigator Video >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).
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 >
