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Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer

NCT01531595 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-12

No results posted yet for this study

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

Conditions

Interventions

DRUG

Bevacizumab plus alternating XELOX/XELIRI

3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression

Sponsors & Collaborators

  • Pia Osterlund

    lead OTHER

Principal Investigators

  • Pia Osterlund, MD · Helsinki University Central Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531595 on ClinicalTrials.gov