Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02363374
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2015-02-03
Brief Title:
Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer
Sponsor:
Prof Dr med Claus Rödel
Organization:
Goethe University
Study Overview
Official Title:
Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer A Randomized Phase II Trial of the German Rectal Cancer Study Group
Status:
COMPLETED
Status Verified Date:
2023-11
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:
CAOAROAIO-12
Brief Summary:
Preoperative 5-FU-based 5-fluorouracil chemoradiotherapy CRT total mesorectal excision surgery and 4 cycles of adjuvant 5-FU - as established by CAOAROAIO-94 - is at present a standard of care for patients with locally advanced rectal cancer UICC stage II and III The phase III German CAOAROAIO-04 trial showed that the addition of oxaliplatin increased treatment efficacy in terms of early secondary efficacy endpoints eg the pCR-rate With a median follow-up of 50 months the primary endpoint of this trial - disease free survival - was significantly improved in the oxaliplatin-containing treatment arm 3-year disease-free survival DFS 712 versus 759 hazard ratio HR 079 95 confidence interval CI 064-098 p003 The hereby proposed randomized phase II trial CAOAROAIO-12 aims at finding novel and innovative aspects of rectal cancer treatment and will thus provide important information for defining the experimental arm in the upcoming large scale trial of the group Compared to the current standard in both study arms the sequence of the three treatment modalities is modified placing the chemotherapy block before surgery The pre-operative sequence of chemotherapy - chemoradiotherapy arm A has been shown to be feasible with no early tumor progression prior to definitive surgical resection in a small randomized phase II study from Spain The sequence chemoradiotherapy - chemotherapy arm B may be beneficial according to response kinetics considerations and by maintaining a highly effective local treatment in the first place Both approaches could avoid the problem of major compliance problems with post-operative adjuvant chemotherapy CAOAROAIO German Rectal Cancer Study Group
Detailed Description:
None
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