Gynaecological

The 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.

 

CAELYX YONDELIS Study

Registered Title

A Randomized, Open-Label Study Comparing the Combination of YONDELIS and CAELYX With CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer.

Purpose

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
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 Healthcare logo

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 Healthcare logo

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 Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Outback Study   

Registered Title

A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone.

Purpose

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer.

Lay Summary

Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet know whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kill more tumor cells.


Who is it for?
You can join this study if you have locally advanced cervical cancer which is suitable for primary treatment with chemoradiation and you have not received any previous pelvic radiotherapy.


Trial details:
Participants will be divided into two groups. Both groups will be treated with standard external beam radiation treatment to the pelvis and brachytherapy(internal radiotherapy). They will receive cisplatin intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. One group will also receive 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin and paclitaxel intravenously, beginning within 4 weeks of completion of all radiation treatment. The study aims to see whether the adjuvant chemotherapy increases the response to treatment and improves survival times.

WA Trial Sites

Sir Charles Gairdner Hospital logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Australian New Zealand Clinical Trials Registry

Acknowledgements: US National Library of Medicine, Australian New Zealand Clinical Trials Registry.

 

Sexual healing

Registered Title

A Randomised, Controlled Trial on the Effect of Pre-Operative Sexual Counselling on Sexuality and Quality of Life after Risk-Reducing Salpingo-oophrectomy.

Purpose

This study will determine the effect of pre-operative sexual counselling on sexuality and quality of life after risk reducing salpingo-oophorectomy (RRSO) in women at high risk of ovarian cancer. 

Lay Summary

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, at high risk of ovarian cancer and have decided to undergo risk-reducing salpingo-oophorectomy.

Study details:

Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a single pre-operative counselling session with a sexologist to discuss the potential effects of surgery on sexual function and physical changes, potential changes to intimacy, loss of sexual self-esteem related to body image changes, menopausal symptoms and confidence, changes to sexual response such as reduced arousal, loss of libido, difficulty reaching orgasm, menopausal symptoms related to treatment including hot flushes/night sweats, disturbed sleep, poor memory and weight gain, all of which may impact on one’s sexual self esteem, sexual functioning and general wellbeing (quality of life).

While participants in the other group will receive routine care which is the initial consultation with your gynaecologic oncology specialist who may or may not discuss such issues with you. Participants will be followed-up for up to 12 months post-surgery to determine the effect on sexual function, the prevalence and severity of sexual difficulties after RRSO, and any other factors that significantly affect sexual function and quality of life. Serum testosterone levels will also be tested to determine whether there is a correlation with sexual function after RRSO.

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

 

Velia Study

Registered Title

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Purpose

The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Vulval Study

Registered Title

Prospective collection of clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand.

Purpose

This study aims to prospectively collect clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand. You may be eligible to join this study if you are a female aged 18 years or above with histologically confirmed, unifocal invasive squamous cell carcinoma of vulva less than 4cm in greatest dimension.

Lay Summary

Women in Australia and New Zealand women with early vulval cancer will be offered sentinel node procedures in place of groin node dissection.

On the day before or the morning of your operation, you will have a small injection of a radioactive marker into the skin next to the cancer. A local anaesthetic cream will be used to reduce any discomfort from this injection. Pictures will then be taken over the next 2 1/2 hours to see which glands the marker has spread to. The marker will also help us find the ‘sentinel nodes’ during your operation. Either on the afternoon after the injection or the next day you will have your operation as planned by your doctor. Whilst you are asleep we will inject some blue dye around the cancer which will also help us to identify the sentinel glands. During the 60 minute operation we will remove the cancer. We will identify and remove the sentinel lymph gland(s) from one or both groins. When sentinel nodes in one or two groins can not be identified a full removal of the groin nodes (lymphadenectomy) on either one or both sides will be performed. The gland(s) will be sent to the laboratory for detailed assessment by the pathologist. Follow up clinical data will be collected from your clinical records at 3, 12, 24 and 36 months after surgery, from information obtained when you attend outpatients clinic. The majority of women with early vulval carcinoma do not have groin node metastasis and these women are unlikely to benefit from groin node dissection. The use of sentinel node dissection is safe and should be part of the standard treatment for women with early stage vulvar cancer.

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

 

 

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