Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-03
Brief Title:
Contact Radiotherapy for Rectal Cancer
Sponsor:
Alexander Valdman
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Contact Radiotherapy for Rectal Cancer CORRECT a Multicenter Randomized Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
CORRECT
Brief Summary:
The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy CXB short-course radiotherapy SCRT compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer cT1-3abN1
Detailed Description:
The primary aim of this study is to determine whether a combination of CXB SCRT is non-inferior to CXB chemoradiotherapy CRT regarding the primary endpoint 2-year organ preservation rate Additionally we hypothesize that a chemotherapy-free radiation-only experimental treatment CXBSCRT is associated with less side-effects compared to the OPERA regime
In the OPERA trial Gerard et al 2023 the CXB was delivered in combination with long-course CRT A combination of short-course radiotherapy SCRT and CXB has previously been used mainly in elderly and comorbid patients not suitable for long-course chemoradiotherapy Recently an international multi-institution report showed good outcomes of planned organ preservation using SCRT together with contact brachytherapy boost However no randomized data on this combination therapy are available There are further no trials comparing CRTCXB and SCRTCXB
Study participants will be randomized to either the standard treatment consisting of CXB 90Gy3 fractions4 weeks and CRT 4550 Gy 182 Gyfraction5 weeks with concurrent chemotherapy using capecitabine 900 mgm2 bid on radiation days OR the experimental treatment consisting of CXB 90Gy3 fractions4 weeks SCRT 25 Gy in 5 daily fractions over a total time of 1 week treating 5 days per week 1 fraction per day using 5 Gy per fraction over the maximum treatment period of eight calendar days
In the OPERA trial Gerard et al 2023 the CXB was delivered in combination with long-course CRT A combination of short-course radiotherapy SCRT and CXB has previously been used mainly in elderly and comorbid patients not suitable for long-course chemoradiotherapy Recently an international multi-institution report showed good outcomes of planned organ preservation using SCRT together with contact brachytherapy boost However no randomized data on this combination therapy are available There are further no trials comparing CRTCXB and SCRTCXB
Study participants will be randomized to either the standard treatment consisting of CXB 90Gy3 fractions4 weeks and CRT 4550 Gy 182 Gyfraction5 weeks with concurrent chemotherapy using capecitabine 900 mgm2 bid on radiation days OR the experimental treatment consisting of CXB 90Gy3 fractions4 weeks SCRT 25 Gy in 5 daily fractions over a total time of 1 week treating 5 days per week 1 fraction per day using 5 Gy per fraction over the maximum treatment period of eight calendar days
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