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To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study (PJEOC)

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgery for EOC with trial (PJ) device (PlasmaJet)
Sponsored by
Dr Thumuluru Kavitha Madhuri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring EOC Epithelial ovarian cancer, Surgery, nil macroscopic residual disease, Stage 3/4 Epithelial Ovarian Cancer requiring surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Surgery without trial (PJ) device

Surgery with trial (PJ) device

Arm Description

Standard debulking surgery for EOC without interventional device

Debulking surgery for EOC with interventional trial device (PJ)

Outcomes

Primary Outcome Measures

Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.

Secondary Outcome Measures

Per-operative morbidity
Post-operative morbidity
Bowel resection rate
Stoma formation rate
Disease Free Survival
Overall Survival
Quality of Life
Quality of life based on validated EORTC questionnaires
Cost-effectiveness
Measured as an incremental cost per Quality of Life Year (QALY)

Full Information

First Posted
May 31, 2014
Last Updated
September 24, 2019
Sponsor
Dr Thumuluru Kavitha Madhuri
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1. Study Identification

Unique Protocol Identification Number
NCT02376231
Brief Title
To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study
Acronym
PJEOC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Thumuluru Kavitha Madhuri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
EOC Epithelial ovarian cancer, Surgery, nil macroscopic residual disease, Stage 3/4 Epithelial Ovarian Cancer requiring surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Surgery without trial (PJ) device
Arm Type
No Intervention
Arm Description
Standard debulking surgery for EOC without interventional device
Arm Title
Surgery with trial (PJ) device
Arm Type
Active Comparator
Arm Description
Debulking surgery for EOC with interventional trial device (PJ)
Intervention Type
Device
Intervention Name(s)
Surgery for EOC with trial (PJ) device (PlasmaJet)
Other Intervention Name(s)
PlasmaJet device
Intervention Description
Debulking surgery for EOC using PJ device
Primary Outcome Measure Information:
Title
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.
Time Frame
At surgery
Secondary Outcome Measure Information:
Title
Per-operative morbidity
Time Frame
30 days
Title
Post-operative morbidity
Time Frame
30 days
Title
Bowel resection rate
Time Frame
6months
Title
Stoma formation rate
Time Frame
6 months
Title
Disease Free Survival
Time Frame
3years
Title
Overall Survival
Time Frame
5 years
Title
Quality of Life
Description
Quality of life based on validated EORTC questionnaires
Time Frame
3 years
Title
Cost-effectiveness
Description
Measured as an incremental cost per Quality of Life Year (QALY)
Time Frame
3years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

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To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study

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