Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249672
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal Cancer With or Without Local Excision After Chemoradiotherapy
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal Cancer With or Without Local Excision After Chemoradiotherapy
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PRESERVE
Brief Summary:
Treatment of rectal cancer by standard neoadjuvant chemoradiotherapy protocols leads to a complete response in about 15 of patients or even a higher fraction if radiotherapy is followed by an Oxaliplatin based chemotherapy as published recently
If patient presents with a near complete response at the time of restaging after neoadjuvant treatment an organ preservation strategy can be an alternative treatment to low anterior resection or abdominoperineal excision of the rectum An organ preserving strategy is an ideal option for patients that are too frail for a major oncological resection Furthermore organ preservation is increasingly an option for a broader spectrum of patients as there is growing evidence that it allows to avoid surgical risks including major dysfunction of the urinary sexual and anorectal function at equivalent oncological outcomes
Studies investigating organ preserving rectal cancer treatment can broadly be divided into two categories The first option is a planned local resection of the remaining scar at the site of the tumor after chemoradiotherapy This can be achieved by direct transanal resection in very low tumors or by an endoscopic procedure as TEM transanal endoscopic microsurgery or TAMIS trans-anal minimally invasive surgery The advantage of this approach is the resulting pathological diagnosis which can confirm the complete response microscopically or indicate if there is remnant tumor tissue left and whether this is completely removed However local resection might have an additional negative functional impact and cumulate with function impairment from chemoradiotherapy
Alternatively patients after complete clinical response can directly enter a surveillance programme without excision of the remaining scar after neoadjuvant treatment This strategy provides less certainty about the complete regression of the primary tumor but allows a treatment completely without surgical interventions and might lead to an even better functional outcome compared to patients undergoing local excision
There is good evidence that the influence of chemoradiotherapy on anorectal and genitourinary function is relevant However there is lack of good quality data how much local excision adds to this impairment on the long run In this study the investigator aims to compare functional outcomes and subjective treatment satisfaction in patients undergoing organ preserving treatment for rectal cancer with and without local resection after chemoradiotherapy This data will help patients and healthcare personal to choose between these treatment options in the future knowing the difference in functional outcome between the groups
As this is an observational study there will not be any influence on treatment decisions for the included subjects Clinical data will be collected by questionnaires and compared between the two cohorts which is in line with a risk category A according to HRO Human Research Ordinance
If patient presents with a near complete response at the time of restaging after neoadjuvant treatment an organ preservation strategy can be an alternative treatment to low anterior resection or abdominoperineal excision of the rectum An organ preserving strategy is an ideal option for patients that are too frail for a major oncological resection Furthermore organ preservation is increasingly an option for a broader spectrum of patients as there is growing evidence that it allows to avoid surgical risks including major dysfunction of the urinary sexual and anorectal function at equivalent oncological outcomes
Studies investigating organ preserving rectal cancer treatment can broadly be divided into two categories The first option is a planned local resection of the remaining scar at the site of the tumor after chemoradiotherapy This can be achieved by direct transanal resection in very low tumors or by an endoscopic procedure as TEM transanal endoscopic microsurgery or TAMIS trans-anal minimally invasive surgery The advantage of this approach is the resulting pathological diagnosis which can confirm the complete response microscopically or indicate if there is remnant tumor tissue left and whether this is completely removed However local resection might have an additional negative functional impact and cumulate with function impairment from chemoradiotherapy
Alternatively patients after complete clinical response can directly enter a surveillance programme without excision of the remaining scar after neoadjuvant treatment This strategy provides less certainty about the complete regression of the primary tumor but allows a treatment completely without surgical interventions and might lead to an even better functional outcome compared to patients undergoing local excision
There is good evidence that the influence of chemoradiotherapy on anorectal and genitourinary function is relevant However there is lack of good quality data how much local excision adds to this impairment on the long run In this study the investigator aims to compare functional outcomes and subjective treatment satisfaction in patients undergoing organ preserving treatment for rectal cancer with and without local resection after chemoradiotherapy This data will help patients and healthcare personal to choose between these treatment options in the future knowing the difference in functional outcome between the groups
As this is an observational study there will not be any influence on treatment decisions for the included subjects Clinical data will be collected by questionnaires and compared between the two cohorts which is in line with a risk category A according to HRO Human Research Ordinance
Detailed Description:
None
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