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

NCT02376231 | Completed DMC

• 1 other identifier: PJEOCRSCH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer

Keywords

EOC Epithelial ovarian cancer; Surgery; nil macroscopic residual disease; Stage 3/4 Epithelial Ovarian Cancer requiring surgery

Outcome Measures

Primary Outcomes (1)

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

  At surgery

Secondary Outcomes (8)

• Per-operative morbidity

  30 days

• Post-operative morbidity

  30 days

• Bowel resection rate

  6months

• Stoma formation rate

  6 months

• Disease Free Survival

  3years

Study Arms (2)

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)

Device: Surgery for EOC with trial (PJ) device (PlasmaJet)

Interventions

Surgery for EOC with trial (PJ) device (PlasmaJet) DEVICE

Debulking surgery for EOC using PJ device

Also known as: PlasmaJet device

Surgery with trial (PJ) device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Thumuluru Kavitha Madhuri: lead

Study Sites (1)

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

Guildford, Surrey, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Surgical Procedures, Operative; Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: May 31, 2014
• First Posted: March 3, 2015
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

GB (1)