A pilot randomised controlled trial to evaluate the utility and efficacy of neutral argon plasma (PlasmaJet®) as a new technology in achieving complete debulking of advanced Epithelial Ovarian Cancer
| ISRCTN | ISRCTN26261491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26261491 |
| EudraCT/CTIS number | 2014-002103-24 |
| Secondary identifying numbers | PJEOC |
- Submission date
- 15/05/2014
- Registration date
- 27/05/2014
- Last edited
- 19/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims:
Surgery for ovarian cancer involves the removal of pelvic organs (the womb, fallopian tubes and ovaries), abdominal organs ( the omentum and the appendix) and any other tissues that may have been affected. The more of the cancer that is removed, the greater the time between the surgery and the cancer coming back and the longer the patient will survive with the disease. Removing all visible signs of a cancer, however, is not easy. The disease is often advanced and widespread and some tumours will be located in sensitive areas such as the surface of the bowel, diaphragm and other important internal structures. In this study, doctors will use a new technology the PlasmaJet to remove tumours that are found in these sensitive areas. The PlasmaJet uses a jet of neutral argon plasma to vaporise the tumours. The PlasmaJet has been used in other areas of medicine, such as sealing bleeding tissue (coagulation) and burning away thin layers of tissue (ablation) but this is the first study that will look at the effects of this technology in ovarian cancer surgery.
Who can participate?
Women with stage III ovarian cancer, that is, with tumours in at least one ovary and where there is evidence that the disease has spread to the abdomen (confirmed peritoneal metastasis outside the pelvis). Patients have to be well enough to cope with the treatment and written consent is obtained in all cases.
What does the study involve?
The study will involve assessing how well the neutral argon plasma (PlasmaJet) technology performs in removing (vapourising) tumours during surgery for ovarian cancer.
What are the possible benefits and risks of participating?
There may not be any immediate benefit to the participants, however the working hypothesis is that it might be safer and faster to debulk ovarian cancer with the PJ device.
Where is the study run from?
Royal Surrey County Hospital, Guildford, UK
When is the study starting and how long is it expected to run for?
March 2013 until the end of December 2017.
Who is funding the study?
GRACE, Department of Gynaecological Oncology, The Royal Surrey County Hospital NHS Foundation Trust, UK
Who is the main contact?
Dr Kavitha Madhuri
Department of Gynaecological Oncology
Royal Surrey County Hospital, Guildford, UK
Contact information
Scientific
Dept. of Gynaecological Oncology
Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU2 7XX
United Kingdom
Study information
| Study design | Pilot, randomised single blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | A pilot, randomised single blind study to evaluate the utility and efficacy of neutral argon plasma as a new technology in achieving complete cytoreduction of advanced epithelial ovarian carcinoma - initial feasibility study |
| Study acronym | PJEOC |
| Study objectives | To evaluate the ability of PJ to achieve optimal cytoreduction (nil visible disease) in women undergoing open debulking surgery for EOC. |
| Ethics approval(s) | National Research Ethics Committee - South East Coast (Surrey), 04/12/2012, ref: 12/LO/1229 |
| Health condition(s) or problem(s) studied | Advanced (Stage 3/4) Epithelial Ovarian Cancer |
| Intervention | This is a initial feasibility pilot RCT. Each participant may be randomised to PJ vs No PJ at the time of their debulking surgery. Each participant will then be followed up for at least the next 5 years. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure is the ability to achieve complete cytoreduction (nil macroscopic residual). To evaluate the ability of PJ to achieve optimal cytoreduction (nil visible disease) in women undergoing open debulking surgery for EOC |
| Secondary outcome measures | 1. To explore if achieving optimal cytoreduction helps increase disease free interval and hence improve survival 2. To categorise the histopathological effects of the depth of tumour destruction of metastatic EOC using the PJ 3. Evaluate the depth of tissue damage caused with a range of power settings and interaction times in vitro following surgery 4. To document the side-effect profile post-operatively following extensive surgery 5. Collate patient reported outcome measures using a validated tool |
| Overall study start date | 01/03/2013 |
| Completion date | 30/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation 2. Confirmation of malignancy on histological/cytological criteria 3. All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment 4. All women fit to undergo treatment 5. No synchronous malignancy likely to interfere with comparisons 6. Written and informed patient consent |
| Key exclusion criteria | 1. Patient choice 2. Patient unfit for any treatment modality 3. Patients who are medically unfit for surgery and would only be suitable for chemotherapy |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 30/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GU2 7XX
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Cathy Mayes
Research & Development Department
Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU2 7XX
England
United Kingdom
"ROR" |
https://ror.org/050bd8661 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/02/2019: Internal review
