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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Kavitha Madhuri
Scientific

Dept. of Gynaecological Oncology
Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU2 7XX
United Kingdom

Study information

Study designPilot, randomised single blind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleA 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 acronymPJEOC
Study objectivesTo 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) studiedAdvanced (Stage 3/4) Epithelial Ovarian Cancer
InterventionThis 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 typeOther
Primary outcome measureThe 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 measures1. 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 date01/03/2013
Completion date30/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants150
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2013
Date of final enrolment30/12/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dept. of Gynaecological Oncology
Guildford
GU2 7XX
United Kingdom

Sponsor information

Royal Surrey County Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Cathy Mayes
Research & Development Department
Royal Surrey County Hospital NHS Foundation Trust
Guildford
GU2 7XX
England
United Kingdom

ROR logo "ROR" https://ror.org/050bd8661

Funders

Funder type

Hospital/treatment centre

GRACE, Department of Gynaecological Oncology, The Royal Surrey County Hospital, UK

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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