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

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ClinicalTrials.gov Identifier: NCT02376231
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Thumuluru Kavitha Madhuri, Royal Surrey County Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Device: Surgery for EOC with trial (PJ) device (PlasmaJet) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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 Name: PlasmaJet device




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

Secondary Outcome Measures :
  1. Per-operative morbidity [ Time Frame: 30 days ]
  2. Post-operative morbidity [ Time Frame: 30 days ]
  3. Bowel resection rate [ Time Frame: 6months ]
  4. Stoma formation rate [ Time Frame: 6 months ]
  5. Disease Free Survival [ Time Frame: 3years ]
  6. Overall Survival [ Time Frame: 5 years ]
  7. Quality of Life [ Time Frame: 3 years ]
    Quality of life based on validated EORTC questionnaires

  8. Cost-effectiveness [ Time Frame: 3years ]
    Measured as an incremental cost per Quality of Life Year (QALY)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376231


Locations
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United Kingdom
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
Dr Thumuluru Kavitha Madhuri

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Responsible Party: Dr Thumuluru Kavitha Madhuri, Clinical Research Fellow, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02376231     History of Changes
Other Study ID Numbers: PJEOCRSCH
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Dr Thumuluru Kavitha Madhuri, Royal Surrey County Hospital NHS Foundation Trust:
EOC Epithelial ovarian cancer
Surgery
nil macroscopic residual disease
Stage 3/4 Epithelial Ovarian Cancer requiring surgery
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma