NCT01811108

Brief Summary

Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

4.4 years

First QC Date

February 21, 2013

Last Update Submit

October 23, 2014

Conditions

Metastatic Colorectal Cancer

Keywords

mCRCKRAS mutationChemotherapyAnti-angiogenic agentBevacizumab1st Line

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with AE

    In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.

    Every 2 weeks up to 12 weeks

Secondary Outcomes (3)

  • Number of Participants with Response Rate

    Disease evaluation at Week 6

  • Percentage of Patients with Progression Free Survival

    1 year

  • Patients Overall Survival

    1 year

Study Arms (1)

Avastin regimens

Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinics for cancer prevention

You may qualify if:

  • Written informed consent
  • Histologically confirmed metastatic or locally advanced non-operable colorectal cancer
  • No prior first line treatment for metastatic colorectal cancer
  • Age ≥18 years
  • One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
  • ECOG performance status ≤2
  • Adequate haematological, renal and hepatic function
  • Urine protein \<2+ (dipstick)
  • Life expectancy of ≥12 weeks

You may not qualify if:

  • Previous first line treatment for metastatic colorectal cancer(progression \>6 months after the end of adjuvant treatment)
  • Previous radiotherapy to target lesions
  • Patients with brain metastases and/or cancerous meningitis
  • Metastatic infiltration \>50% of the liver parenchyma
  • Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
  • Patients participating in interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Vassilis Georgoulias, MD

    Hellenic Oncology Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

March 14, 2013

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

GR(6)