Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-01 @ 6:56 AM
Study NCT ID:
NCT01531595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2012-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer
Sponsor:
Pia Osterlund
Organization:
Study Overview
Official Title:
Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
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:
AXOAXI
Brief Summary:
* Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
* Primary objective: Progression Free Survival (PFS),
* To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
* Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
* Primary objective: Progression Free Survival (PFS),
* To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
* Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: