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

September 24, 2019 updated by: Dr Thumuluru Kavitha Madhuri

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Surgery without trial (PJ) device
Standard debulking surgery for EOC without interventional device
Active Comparator: Surgery with trial (PJ) device
Debulking surgery for EOC with interventional trial device (PJ)
Device: Surgery for EOC with trial (PJ) device (PlasmaJet)
Debulking surgery for EOC using PJ device
Other Names:
  • PlasmaJet device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.
Time Frame: At surgery
At surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
5 years
Disease Free Survival
Time Frame: 3years
3years
Per-operative morbidity
Time Frame: 30 days
30 days
Post-operative morbidity
Time Frame: 30 days
30 days
Bowel resection rate
Time Frame: 6months
6months
Stoma formation rate
Time Frame: 6 months
6 months
Quality of Life
Time Frame: 3 years
Quality of life based on validated EORTC questionnaires
3 years
Cost-effectiveness
Time Frame: 3years
Measured as an incremental cost per Quality of Life Year (QALY)
3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Thumuluru Kavitha Madhuri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 31, 2014

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJEOCRSCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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