Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402864
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Multicenter Randomized Phase III Trial Evaluating Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
TRESOR
Brief Summary:
Indication Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy TNT potentially eligible for rectal preservation
Primary objective is to assess efficacy of contact X-ray brachytherapy CXB in addition to TNT in order to increase survival with organ preservation OP in selected intermediate risk group of rectal adenocarcinomas size from 35 to 6 cm cT2N1 or T3N0-1 M0
Primary objective is to assess efficacy of contact X-ray brachytherapy CXB in addition to TNT in order to increase survival with organ preservation OP in selected intermediate risk group of rectal adenocarcinomas size from 35 to 6 cm cT2N1 or T3N0-1 M0
Detailed Description:
It is an open label phase III randomized controlled clinical trial comparing 2 arms
Control arm A consists in TNT regimen with an induction chemotherapy Modified FOLFIRINOX mFOLFIRINOX 6 cycles over 12 weeks followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine CAP50 Gy
Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT
Clinical endoscopic and radiological evaluation will be performed 7 weeks after the end of nCRT in both arms
In case of cCR local excision or surveillance will be proposed to patients regarding center choice
In the absence of cCR patients will be treated by TME followed by adjuvant chemotherapy mFOLFOX 6 cycles or capecitabine 3 cycles over 12 weeks
Control arm A consists in TNT regimen with an induction chemotherapy Modified FOLFIRINOX mFOLFIRINOX 6 cycles over 12 weeks followed by nCRT 50 Gy over 5 weeks with concomitant capecitabine CAP50 Gy
Experimental arm B consists in addition of three fractions of CXB every two weeks between end of mFOLFIRINOX and nCRT
Clinical endoscopic and radiological evaluation will be performed 7 weeks after the end of nCRT in both arms
In case of cCR local excision or surveillance will be proposed to patients regarding center choice
In the absence of cCR patients will be treated by TME followed by adjuvant chemotherapy mFOLFOX 6 cycles or capecitabine 3 cycles over 12 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20233684 | OTHER | CSET number | None |