NCT02075086

Brief Summary

A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jul 2011

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

November 17, 2011

Last Update Submit

March 13, 2015

Conditions

Colorectal Cancer

Keywords

angiogenic switchplasma cytokinesColon cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Days from cycle one day one to progression

    1 year

Secondary Outcomes (1)

  • Feasibility

    2 years

Study Arms (1)

Chemotherapy treatment

EXPERIMENTAL

Chemotherapy treatment with Xelox or Xeliri and bevacizumab

Drug: Xelox or Xeliri Bevacizumab

Interventions

Xelox or Xeliri BevacizumabDRUG

Chemotherapy treatment

Also known as: Cytokines measure, Angiogenic study
Chemotherapy treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stage IV colorectal adenocarcinoma.
  • Age ≥ 18 years .
  • Measurable disease by RECIST criteria.
  • Life expectancy ≥ 6 months.
  • Candidate to receive treatment with first-line chemotherapy.
  • Availability of tumor tissue.

You may not qualify if:

  • Patients who have received prior treatment with first-line chemotherapy for metastatic disease.
  • Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev.
  • Patients receiving anticoagulant oral treatment.
  • Patients with bone disease as the only manifestation of the disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Integral oncológico Clara Campal

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonio Cubillo, MD PhaD

    Grupo Hospital de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2011

First Posted

March 3, 2014

Study Start

July 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

ES(1)