Epithelial Ovarian CancerPJEOCNCT02376231
To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study
A study testing Surgery for EOC with trial (PJ) device (PlasmaJet) in people with Epithelial Ovarian Cancer, run by Dr Thumuluru Kavitha Madhuri at 1 site in United Kingdom.
Trial summary
Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Surgery for EOC with trial (PJ) device (PlasmaJet)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation.
- Confirmation of malignancy on histological/cytological criteria.
- All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment.
- All women fit to undergo treatment.
- No synchronous malignancy likely to interfere with comparisons.
- Written and informed patient consent
Who cannot join
- Patient choice
- Patient unfit for any treatment modality
- Patients who are medically unfit for surgery and would only be suitable for chemotherapy.
- WITHDRAWAL CRITERIA
- Unforeseen complications in the individual patient will be recorded and then analysed.
- Life threatening situation to the patient, due to any other unrelated complication.
- Patients are free to withdraw from the study at any time with no impact on their care whatsoever.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
Official title: A Pilot Single Blinded Randomized Controlled Trial 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
Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Surgery for EOC with trial (PJ) device (PlasmaJet)
- Keywords
- EOC Epithelial ovarian cancer, Surgery, nil macroscopic residual disease, Stage 3/4 Epithelial Ovarian Cancer requiring surgery
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for EOC with trial (PJ) device (PlasmaJet)Device
Also called PlasmaJet device
Debulking surgery for EOC using PJ device
| Study group | Role | What they receive |
|---|---|---|
| Standard Surgery without trial (PJ) device | No intervention | Standard debulking surgery for EOC without interventional device |
| Surgery with trial (PJ) device | Active comparator | Debulking surgery for EOC with interventional trial device (PJ) Receives: Device: Surgery for EOC with trial (PJ) device (PlasmaJet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.
Measured: At surgery
Secondary outcomes (8)
Per-operative morbidity
Measured: 30 days
Post-operative morbidity
Measured: 30 days
Bowel resection rate
Measured: 6months
Stoma formation rate
Measured: 6 months
Disease Free Survival
Measured: 3years
Overall Survival
Measured: 5 years
Quality of Life
Quality of life based on validated EORTC questionnaires
Measured: 3 years
Cost-effectiveness
Measured as an incremental cost per Quality of Life Year (QALY)
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Thumuluru Kavitha Madhuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Thumuluru Kavitha Madhuri, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376231
- Sponsor's protocol ID
- PJEOCRSCH
- Acronym
- PJEOC
- Status last verified
- Sep 2019
- First submitted
- 31 May 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single Blinded Randomized Controlled Trial 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
- ClinicalTrials.gov ID
- NCT02376231
- Acronym / sponsor ID
- PJEOC / PJEOCRSCH
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- EOC Epithelial ovarian cancer, Surgery, nil macroscopic residual disease, Stage 3/4 Epithelial Ovarian Cancer requiring surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dr Thumuluru Kavitha MadhuriUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Surgery without trial (PJ) device | No intervention | –Standard debulking surgery for EOC without interventional device |
| Surgery with trial (PJ) device | Active comparator | Device: Surgery for EOC with trial (PJ) device (PlasmaJet)Debulking surgery for EOC with interventional trial device (PJ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation.
- Confirmation of malignancy on histological/cytological criteria.
- All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment.
- All women fit to undergo treatment.
- No synchronous malignancy likely to interfere with comparisons.
Key exclusion criteria (7 listed)
- Patient choice
- Patient unfit for any treatment modality
- Patients who are medically unfit for surgery and would only be suitable for chemotherapy.
- WITHDRAWAL CRITERIA
- Unforeseen complications in the individual patient will be recorded and then analysed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for EOC with trial (PJ) device (PlasmaJet)Also: PlasmaJet deviceDebulking surgery for EOC using PJ device | Device | Surgery with trial (PJ) device |
Primary outcome
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.
Time frame: At surgery
8 secondary outcomes
Per-operative morbidity
Time frame: 30 days
Post-operative morbidity
Time frame: 30 days
Bowel resection rate
Time frame: 6months
Stoma formation rate
Time frame: 6 months
Disease Free Survival
Time frame: 3years
Overall Survival
Time frame: 5 years
Quality of Life
Time frame: 3 years
Cost-effectiveness
Time frame: 3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for EOC with trial (PJ) device (PlasmaJet) in people with Epithelial Ovarian Cancer, run by Dr Thumuluru Kavitha Madhuri at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ. (time frame: At surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.