ANZGOG GYNAECOLOGICAL CLINICAL TRIALS

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.

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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.

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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.

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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.

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EPOCH is a Phase II open label international clinical trial, which seeks to improve outcomes in women with tubo-ovarian or uterine carcinosarcoma by providing patients with access to a treatment that offers a greater degree of clinical benefit compared to currently available standard chemotherapeutic options.

Eligibility Criteria

Women with histologically confirmed ovarian/fallopian tube carcinosarcoma uterine cancer or uterine carcinosarcoma (OCS or UCS) with evidence of recurrence or progression after the completion of at least one line and not more than two lines of chemotherapy may be eligible.

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HyNOVA is a randomised study comparing hyperthermic and normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial ovarian, fallopian tube and primary peritoneal cancer.

Eligibility Criteria

Women diagnosed with primary FIGO stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. Histopathology must be high grade serous, endometroid (grade 2 and 3), clear cell adenocarcinoma or mixed high grade histologies.

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IGNITE is testing how effective adavosertib treatment is for patients with relapsed high grade serous or endometrioid ovarian cancer with particular genetic faults, which alter how tumour cells respond to treatment.

Eligibility Criteria

Women with recurrent platinum resistant high grade serous ovarian cancer with Cyclin E1 over-expression with and without high level CCNE1 amplification.

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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.

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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.

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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).

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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.

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