Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427375
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2007-01-26
Brief Title:
Local Excision in Downstaged Rectal Cancer
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Status:
COMPLETED
Status Verified Date:
2018-03
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:
GRECCAR 2
Brief Summary:
Patients with T2T3 low rectal cancer size 4 cm received neoadjuvant treatment 50Gy in 5 weeks with concomitant chemotherapy Good responders residual tumour 2 cm are randomised in local vs rectal excision 6-8 weeks after treatment The composite end point evaluates the rate of patients with death recurrence major morbidity or severe after effects at two years
Detailed Description:
Rectal excision is the standard surgical treatment of rectal cancer The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments Local excision is a conservative alternative approach associated with low mortality and morbidity The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer
Patients with T2T3 low rectal cancer less than 8 cm from the anal verge size 4 cm received neoadjuvant treatment included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least one fluoropyrimidine
Good clinical responders residual tumour 2 cm are randomised in local vs rectal excision 6-8 weeks after treatment In case of not confirmed pathological response following local excision complementary rectal excision is required
Bad responders residual tumour 2cm are treated by primary rectal excision Follow-up includes digital rectal examination CT-scan and endorectal ultrasound if local excision every 4 months for 2 years then every 6 months for 3 years
Patients with T2T3 low rectal cancer less than 8 cm from the anal verge size 4 cm received neoadjuvant treatment included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least one fluoropyrimidine
Good clinical responders residual tumour 2 cm are randomised in local vs rectal excision 6-8 weeks after treatment In case of not confirmed pathological response following local excision complementary rectal excision is required
Bad responders residual tumour 2cm are treated by primary rectal excision Follow-up includes digital rectal examination CT-scan and endorectal ultrasound if local excision every 4 months for 2 years then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-025 | None | None | None |