Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838496
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-04-09
First Post:
2021-04-02
Brief Title:
Induction Chemotherapy for Locally Advanced Rectal Cancer
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
Neo-adjuvant FOLFOXIRI and Chemoradiotherapy for High Risk Ugly Locally Advanced Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
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:
MEND-IT
Brief Summary:
Despite developments in the multidisciplinary treatment of patients with locally advanced rectal cancer LARC such as the introduction of total mesorectal excision TME by Heald et al and the shift from adjuvant to neoadjuvant chemoradiotherapy CRT local and distant recurrence rates remain between 5-10 and 25-40 respectively Several studies established tumour characteristics with particularly bad prognosis it was demonstrated that the occurrence of mesorectal fascia involvement MRF grade 4 extramural venous invasion EMVI tumour deposits TD and enlarged lateral lymph nodes LLN lead to high local and distant recurrence rates and decreased survival when compared with LARC without these particularly negative prognostic factors This type of LARC is described as high risk LARC hr-LARC Achieving a resection with clear resection margins R0 is an important prognostic factor for local LR and distant recurrence DM as well as survival With the aim to further reduce the risk of recurrent rectal cancer to diminish distant metastasis and to improve overall survival for patients with LARC induction chemotherapy ICT became a growing area of research The addition of ICT has the ability to induce more local tumour downstaging possibly leading to resectability of previously unresectable tumours more R0 resections and less extensive surgery In the case of a complete clinical response surgery may even be omitted ICT may also have the potential to eradicate micrometastases Hence increased local downstaging and reducing distant metastatic spread may reduce LR and DM rates and improve survival and quality of life In recent years the use of ICT was investigated and showed promising results but little is known about the addition of ICT in patients with high risk LARC Since these patients have a particularly bad prognosis both with regard to locoregional and distant failure a more intensified neoadjuvant treatment with FOLFOXIRI is anticipated to improve short- and long term results
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