Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960630
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-06-17
Brief Title:
MIRRORS-RCT Pilot Role of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Cancer
Sponsor:
Royal Surrey County Hospital NHS Foundation Trust
Organization:
Royal Surrey County Hospital NHS Foundation Trust
Study Overview
Official Title:
MIRRORS-RCT Pilot Randomised Controlled Trial RCT of Robotic Interval Cytoreductive Surgery for Advanced Ovarian Fallopian Tube and Peritoneal Cancer EOC Following MIRRORS-protocol vs Standard Open Interval Cytoreductive Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRRORS-RCTP
Brief Summary:
The survival of ovarian cancer patients is dependent on the stage at diagnosis more than 70 of patients present with advanced stage disease stage IIIIV In England one-year survival is 987 at stage I and 514 at stage IV and five-year survival is 933 and 134 respectively Standard treatment for advanced ovarian cancer involves surgery to remove all visible tumour and chemotherapy Removal of all visible disease so no tumour deposits are visible to the naked eye at the end of first-line surgery is one of the strongest predictors of overall survival
A majority of the women presenting with advanced disease are older and frail Extensive open surgery discriminates against such women as they may not be well enough for the surgery offered A recent national audit in England found that 601 of women over the age of 79yrs diagnosed with ovarian cancer received no cancer treatment at all The ability to provide the same surgery via a minimally invasive route such as robotic surgery potentially widens access to cancer treatment
The MIRRORS Feasibility study NCT04402333 completed recently at the Royal Surrey County Hospital in Guildford showed significantly enhanced recovery with short length of stay and reduced blood loss enabling faster recommencement of chemotherapy in women with advanced disease undergoing robotic surgery compared to open surgery requiring a cut in the abdomen
In the current proposed study funded by Intuitive Foundation and GRACE Charity the investigators will establish the feasibility of conducting a randomised controlled trial and collect data from three hospital sites to inform a future phase 3 randomised controlled trial The aim will be to to improve patient experience access to surgery recovery reduce morbidity and reduce time to chemotherapy by incorporating robotic cytoreductive surgery into the ovarian cancer treatment pathway for women with a pelvic mass 8cm
A majority of the women presenting with advanced disease are older and frail Extensive open surgery discriminates against such women as they may not be well enough for the surgery offered A recent national audit in England found that 601 of women over the age of 79yrs diagnosed with ovarian cancer received no cancer treatment at all The ability to provide the same surgery via a minimally invasive route such as robotic surgery potentially widens access to cancer treatment
The MIRRORS Feasibility study NCT04402333 completed recently at the Royal Surrey County Hospital in Guildford showed significantly enhanced recovery with short length of stay and reduced blood loss enabling faster recommencement of chemotherapy in women with advanced disease undergoing robotic surgery compared to open surgery requiring a cut in the abdomen
In the current proposed study funded by Intuitive Foundation and GRACE Charity the investigators will establish the feasibility of conducting a randomised controlled trial and collect data from three hospital sites to inform a future phase 3 randomised controlled trial The aim will be to to improve patient experience access to surgery recovery reduce morbidity and reduce time to chemotherapy by incorporating robotic cytoreductive surgery into the ovarian cancer treatment pathway for women with a pelvic mass 8cm
Detailed Description:
Hypothesis in selected cases of epithelial ovarian cancer EOC following neoadjuvant chemotherapy robotic surgery is safe and acceptable facilitates maximal debulking surgery and is associated with improved patient outcomes
MIRRORS- RCT Pilot is a Randomised controlled trial RCT to establish whether the MIRRORS protocol can operate successfully as an RCT at other sites that patients are willing to be recruited and randomised before commencing a national multicentre trial The aim is to provide proof of the concept that a larger adequately powered multi-centre RCT is feasible
All Women with Stage 3c or greater EOC with a pelvic mass 8cm will be identified at diagnosis from the first MDT discussion All patients will have a CT at presentation which will be used to screen women as suitable or not for inclusion Potential eligible participants will be offered inclusion and provided with a participant information leaflet and study consent form to consider for at least 24 hours prior to review in clinic Participants opting to participate will then undergo the consent process They will sign the study consent form following discussion and have the opportunity to ask any questions they wish This consent process will be carried out with an experienced member of the clinical team who is authorised trained and competent to do so Participants will then be asked to complete baseline questionnaires
All screened patients will have the following anonymised basic information collected date of birth age ethnicity reason not eligible and reason for declining if eligible but declined
Participants found to have progressive disease will not be offered cytoreductive surgery and will then be excluded from the trial
Following recruitment to the study eligible patients will be randomised by the PI or delegated member of the clinical investigating team at local sites in a 21 ratio MIRRORS vs standard management SM using the Sealed Envelope randomisation service Eligibility and consent will be verified before each patient is randomised
The two arms of the study are
MIRRORS Protocol Diagnostic Laparoscopy proceed to either robotic or open Interval cytoreductive surgery with conversion to open at any point should this be required to remove all visible disease
Standard Open Interval Cytoreductive Surgery Surgery will proceed directly with standard open interval cytoreductive surgery through an extended midline incision
A surgery date will be arranged enabling all randomised patients are booked onto an appropriate theatre list robotic or open with an appropriately experienced surgeon This will ensure that robotic resources and theatre time is not wasted
Patients surgeons and treating physicians will not be blinded to the treatment However the statistician conducting the analysis will be blinded to the treatment allocation
At the second MDT review following a CT performed after 2 or 3 cycles of chemotherapy some randomised patients may have to be excluded from the study at this point for example due to disease progression It is expected that the attrition will be balanced between treatment arms but it is possible that given the relatively small numbers included in the study there may be some imbalance in the groups at the end of the recruitment period
As is standard practice the surgery will be discussed in detail and informed consent for the surgery will be undertaken during the participants next clinic visit Consent will be re-confirmed on the morning of surgery All participants who join the study are free to change their mind and withdraw at any time during the study The decision will not affect their care in any way The anonymised data that is collected up to the point of withdrawing can still be used in the final analysis of the results unless the participant does not wish this to happen In such cases the investigators will destroy the data Participants GP will be informed that they are taking part in the study Consent for informing the GP forms part of the study consent form
At the time of surgery the standard practice for advanced ovarian cancer would be to proceed with an extended vertical cut on the abdomen to remove as much tumour as possible Participants who are randomised to MIRRORS protocol will start the surgery with an initial laparoscopic assessment a camera inserted though the belly button This visual assessment is used to determine whether it is feasible to proceed with surgery robotically or whether full cytoreductive surgery to zero macroscopic residual disease would be best carried out through an open surgical approach
If an open surgical approach is considered the optimum treatment for the patient and they have consented for this then this will be done If there is disease that cannot be removed robotically after starting by this route but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so If there are any complications the investigators may also need to convert to open surgery Participants randomised to standard cytoreductive surgery will receive standard cytoreductive surgery through a midline laparotomy The aim of the surgery whether by robotic or open is to remove all visible disease safely
The study will involve questionnaires relating to recovery and quality of life and pain these are established validated questionnaires two are from the European Organisation for Research and Treatment of Cancer EORTC QLQ C30 EORTC QLQ OV28Another is the Hospital Anxiety and Depression Scale which is used to assess levels of anxiety and depression that a person is experiencing The EQ5D-5L questionnaire will be used to gather health economic data Lastly the investigators will be using a simple 11-point pain scale 0-10 to assess participants pain These questionnaires will be completed at certain time points starting at baseline and then following on from surgery
Study participants will be followed up during their normal scheduled appointment times as per the standard of care There will be no additional screening bloods or investigations beyond that already done as part of the surgical work up If necessary questionnaires can be completed by telephone included in the study consent form
Collection of PROMs will be carried out via the web-based portal using computers tablet or smartphone devices Data security is paramount with regular penetration testing Information is stored according to national standards and no identifiable data is stored on internet connected devicesdatabase Account details are stored on internally hosted servers and authenticated through SSL encrypted web services Upon consent participants will be provided with a login to facilitate their access to the platform and offered access to the Database This is provided in an email triggered by initial participant registration following initial contact in clinic
The email provides a unique identifier which allows participants to access their assigned PROMs surveys for completion Once the appropriate PROMs questionnaire is completed the data is then stored in the platform additionally a notification is sent to the research team system so that they can confirm completion status for their participants It is also possible for participants who do not have an email address to be recruited into the study by allocating them with a username and password and if they dont have their own computer they can use it with either a Trust computer or a public device eg in a library
At least one face to face or remote proctoring session will be carried out to vet all new sites enrolled in MIRRORS RCT pilot to ensure that surgeons participating in the MIRRORS protocol arm of MIRRORS-RCT pilot are suitably experienced regarding the MIRRORS-Protocol and trained to do so
The investigators aim to recruit 20 women across 3 sites within a 6-8 months recruitment window The sample size is set pragmatically to give precision in the estimate of pre-defined feasibility criteria parameters such as consent rate robotic operation rate and success rate target debulking of R0 achieved with timely recruitment Inclusion of 20 women is sufficient to ensure these rates can be estimated within a standard error of less than 10 providing maximal confidence intervals for percentage estimates of -20
MIRRORS- RCT Pilot is a Randomised controlled trial RCT to establish whether the MIRRORS protocol can operate successfully as an RCT at other sites that patients are willing to be recruited and randomised before commencing a national multicentre trial The aim is to provide proof of the concept that a larger adequately powered multi-centre RCT is feasible
All Women with Stage 3c or greater EOC with a pelvic mass 8cm will be identified at diagnosis from the first MDT discussion All patients will have a CT at presentation which will be used to screen women as suitable or not for inclusion Potential eligible participants will be offered inclusion and provided with a participant information leaflet and study consent form to consider for at least 24 hours prior to review in clinic Participants opting to participate will then undergo the consent process They will sign the study consent form following discussion and have the opportunity to ask any questions they wish This consent process will be carried out with an experienced member of the clinical team who is authorised trained and competent to do so Participants will then be asked to complete baseline questionnaires
All screened patients will have the following anonymised basic information collected date of birth age ethnicity reason not eligible and reason for declining if eligible but declined
Participants found to have progressive disease will not be offered cytoreductive surgery and will then be excluded from the trial
Following recruitment to the study eligible patients will be randomised by the PI or delegated member of the clinical investigating team at local sites in a 21 ratio MIRRORS vs standard management SM using the Sealed Envelope randomisation service Eligibility and consent will be verified before each patient is randomised
The two arms of the study are
MIRRORS Protocol Diagnostic Laparoscopy proceed to either robotic or open Interval cytoreductive surgery with conversion to open at any point should this be required to remove all visible disease
Standard Open Interval Cytoreductive Surgery Surgery will proceed directly with standard open interval cytoreductive surgery through an extended midline incision
A surgery date will be arranged enabling all randomised patients are booked onto an appropriate theatre list robotic or open with an appropriately experienced surgeon This will ensure that robotic resources and theatre time is not wasted
Patients surgeons and treating physicians will not be blinded to the treatment However the statistician conducting the analysis will be blinded to the treatment allocation
At the second MDT review following a CT performed after 2 or 3 cycles of chemotherapy some randomised patients may have to be excluded from the study at this point for example due to disease progression It is expected that the attrition will be balanced between treatment arms but it is possible that given the relatively small numbers included in the study there may be some imbalance in the groups at the end of the recruitment period
As is standard practice the surgery will be discussed in detail and informed consent for the surgery will be undertaken during the participants next clinic visit Consent will be re-confirmed on the morning of surgery All participants who join the study are free to change their mind and withdraw at any time during the study The decision will not affect their care in any way The anonymised data that is collected up to the point of withdrawing can still be used in the final analysis of the results unless the participant does not wish this to happen In such cases the investigators will destroy the data Participants GP will be informed that they are taking part in the study Consent for informing the GP forms part of the study consent form
At the time of surgery the standard practice for advanced ovarian cancer would be to proceed with an extended vertical cut on the abdomen to remove as much tumour as possible Participants who are randomised to MIRRORS protocol will start the surgery with an initial laparoscopic assessment a camera inserted though the belly button This visual assessment is used to determine whether it is feasible to proceed with surgery robotically or whether full cytoreductive surgery to zero macroscopic residual disease would be best carried out through an open surgical approach
If an open surgical approach is considered the optimum treatment for the patient and they have consented for this then this will be done If there is disease that cannot be removed robotically after starting by this route but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so If there are any complications the investigators may also need to convert to open surgery Participants randomised to standard cytoreductive surgery will receive standard cytoreductive surgery through a midline laparotomy The aim of the surgery whether by robotic or open is to remove all visible disease safely
The study will involve questionnaires relating to recovery and quality of life and pain these are established validated questionnaires two are from the European Organisation for Research and Treatment of Cancer EORTC QLQ C30 EORTC QLQ OV28Another is the Hospital Anxiety and Depression Scale which is used to assess levels of anxiety and depression that a person is experiencing The EQ5D-5L questionnaire will be used to gather health economic data Lastly the investigators will be using a simple 11-point pain scale 0-10 to assess participants pain These questionnaires will be completed at certain time points starting at baseline and then following on from surgery
Study participants will be followed up during their normal scheduled appointment times as per the standard of care There will be no additional screening bloods or investigations beyond that already done as part of the surgical work up If necessary questionnaires can be completed by telephone included in the study consent form
Collection of PROMs will be carried out via the web-based portal using computers tablet or smartphone devices Data security is paramount with regular penetration testing Information is stored according to national standards and no identifiable data is stored on internet connected devicesdatabase Account details are stored on internally hosted servers and authenticated through SSL encrypted web services Upon consent participants will be provided with a login to facilitate their access to the platform and offered access to the Database This is provided in an email triggered by initial participant registration following initial contact in clinic
The email provides a unique identifier which allows participants to access their assigned PROMs surveys for completion Once the appropriate PROMs questionnaire is completed the data is then stored in the platform additionally a notification is sent to the research team system so that they can confirm completion status for their participants It is also possible for participants who do not have an email address to be recruited into the study by allocating them with a username and password and if they dont have their own computer they can use it with either a Trust computer or a public device eg in a library
At least one face to face or remote proctoring session will be carried out to vet all new sites enrolled in MIRRORS RCT pilot to ensure that surgeons participating in the MIRRORS protocol arm of MIRRORS-RCT pilot are suitably experienced regarding the MIRRORS-Protocol and trained to do so
The investigators aim to recruit 20 women across 3 sites within a 6-8 months recruitment window The sample size is set pragmatically to give precision in the estimate of pre-defined feasibility criteria parameters such as consent rate robotic operation rate and success rate target debulking of R0 achieved with timely recruitment Inclusion of 20 women is sufficient to ensure these rates can be estimated within a standard error of less than 10 providing maximal confidence intervals for percentage estimates of -20
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None