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Gynaecological

he following list provides a brief description of gynaecological cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

EMPOWER

Registered Title	An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Therapy of Investigator's Choice Chemotherapy in Recurrent or Metastatic Platinum-Refractory Cervical Carcinoma
Purpose	The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's choice (IC) chemotherapy.
Lay Summary	N/A
WA Trial Sites	St John of God Subiaco Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

feMMe Endometrial Cancer Study

Registered Title	A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium.
Purpose	Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for: young women who still wish to have children and would lose fertility; and women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe. This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary. Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).
Lay Summary	N/A
WA Trial Sites	St John of God Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

FROCS

Registered Title	Mindfulness Based Cognitive Therapy for Fear of Recurrence in Ovarian Cancer Survivors. (FROCS)
Purpose	This study will determine the effect of mindfulness based cognitive therapy on the fear of recurrence in ovarian cancer survivors.
Lay Summary	Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with ovarian cancer, have completed all hospital based adjuvant treatment and are now disease free. Study details: All participants will receive the same intervention and will involve intensive training and practice in mindfulness based cognitive therapy. Treatment is designed as an 8 week course of 2-2.5 hour small group sessions once weekly with approximately 8-15 individuals in each group. Sessions are run at locations in Shenton Park, Duncraig and East Fremantle by the Cancer Council WA, or by SolarisCare Foundation, at Sir Charles Gardner Hospital in Nedlands. Courses take place during the day and are free of charge. The groups will be run by experienced clinicians in psychotherapy, counselling and meditation and will have a clinician manual and a participant workbook outlining the themes and exercises for each week. Group members will be expected to practice skills between sessions. Participants will be asked to answer questionnaires before, during and after the group sessions to collect information on how participants are feeling.
WA Trial Sites	St John of God Ph. (08) 6465 9204
Links	Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

LACC Cervical Cancer Study

Registered Title	A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer.
Purpose	The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.
Lay Summary	N/A
WA Trial Sites	St John of God Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

PHAEDRA

Registered Title	"A Phase II trial of durvalumab (Medi 4736) in advanced endometrial cancer A multi-centre Phase II trial to determine the activity and safety of durvalumab in advanced endometrial cancer"
Purpose	The primary purpose of this trial is to evaluate the safety and efficacy of durvalumab for the treatment of advanced endometrial cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced endometrial carcinoma which is suitable for chemotherapy.
Lay Summary	N/A
WA Trial Sites	SCGH Medical Oncology Ph. (08) 6383 3000
Links	Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

STATEC

Registered Title	A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.
Purpose	STATEC is testing the use of a surgical procedure called lymphadenectomy (or lymph gland removal) to help guide further treatment in women with endometrial (womb) cancer. In patients who undergo lymph gland removal, the results of the lymph gland removal (e.g. node negative or node positive) will be used to select further (adjuvant) treatment.Patients will be randomised to one of the following two arms, either prior to surgery or following hysterectomy and bilateral salpingo-oophorectomy (BSO):Group 1: Randomised treatment will be hysterectomy and BSO, plus lymphadenectomy. Patients randomised prior to hysterectomy and BSO will receive the lymphadenectomy as part of the same operation as the hysterectomy and BSO. Patients randomised after hysterectomy and BSO will receive the lymphadenectomy as a separate operation. Adjuvant treatment will then be determined by lymph node status. Node positive patients will receive adjuvant treatment to include chemotherapy with or without external radiotherapy, while node negative patients will receive brachytherapy (internal radiotherapy) only.Group 2: Randomised treatment will be a hysterectomy and BSO without lymphadenectomy. Patients randomised after hysterectomy and BSO will receive no further surgery. Patients will then receive adjuvant treatment to include chemotherapy with or without external radiotherapy.The chemotherapy, external radiotherapy and/or brachytherapy for patients in both Group 1 and Group 2 will be given as per standard practice at the treating hospital.
Lay Summary	N/A
WA Trial Sites	St John of God - Subiaco Ph. (08) 6465 9204
Links	Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

EXCISE

Registered Title	Excisional treatment in women with cervical adenocarcinoma-in-situ (AIS): a prospective randomised controlled non-inferiority trial to compare AIS persistence/recurrence after loop electrosurgical excision procedure to cold knife cone biopsy.
Purpose	The aim of this pilot study is to compare loop electrosurgical excision procedure to cold knife cone biopsy for treatment of adenocarcinoma in situ.
Lay Summary	Who is it for? You may be eligible to join this study if you are a woman aged between 18 and 45 years old and have been diagnosed with adenocarcinoma in situ (AIS) with lesions amenable to single pass excision. Study details AIS most frequently occurs in young women (less than 45 years of age) who may wish to preserve their fertility. If this is the case, there are two treatment options available: cold knife cone (CKC) biopsy or loop electrosurgical excisional procedure (LEEP).
WA Trial Sites	St John of God - Subiaco (08) 6465 9204
Links	Australian and New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

iPRIME

Registered Title	A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers â€œiPRIMEâ€.
Purpose	The purpose of this research project is to test how safe and effective the combination treatment of durvalumab and tremelimumab in combination with standard chemotherapy is as a treatment for patients with ovarian, fallopian tube or peritoneal cancers.
Lay Summary	Who is it for? You may be eligible to join this study if you are a female aged 18 years or older with a confirmed diagnosis of stage III or IV high grade serous ovarian, fallopian tube, or peritoneal carcinoma, and a life expectancy of at least 12 weeks. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive [18 weeks/6 cycles] of treatment with Carboplatin, paclitaxel combined with durvalumab and tremelimumab (Du-T-NACT) administered intravenously (i.e. directly into the vein). This will then be followed by maintenance therapy with Durvalumab (every 4 weeks) and Tremelimumab (every 12 weeks) for 36 weeks or until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Durvalumab and tremelimumab are new drugs which are designed to increase the body's immune response. Participants in the other group will receive [18 weeks/6 cycles] of chemotherapy with Carboplatin and paclitaxel only, followed by an observation period, which involves 4 weekly CA-125 assessments. Participants in both groups may also undergo interval debulking surgery after 3 cycles of treatment, if suitable.
WA Trial Sites	Linear Clinical Research 0437 873 044
Links	Australian and New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

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