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Angiogenic Switch in Patients With Colorectal Cancer (ANGIOSWITCH)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Xelox or Xeliri Bevacizumab
Sponsored by
Grupo Hospital de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring angiogenic switch, plasma cytokines, Colon cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually
  • Patients with bone disease as the only manifestation of the disease.

Sites / Locations

  • Centro Integral oncológico Clara Campal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy treatment

Arm Description

Chemotherapy treatment with Xelox or Xeliri and bevacizumab

Outcomes

Primary Outcome Measures

Progression Free Survival
Days from cycle one day one to progression

Secondary Outcome Measures

Feasibility
Feasibility of doing a clinical prospective trial with a measure od plasma citoquines.

Full Information

First Posted
November 17, 2011
Last Updated
March 13, 2015
Sponsor
Grupo Hospital de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02075086
Brief Title
Angiogenic Switch in Patients With Colorectal Cancer
Acronym
ANGIOSWITCH
Official Title
Angiogenic Switch as Predictor of Response to Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Hospital de Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
angiogenic switch, plasma cytokines, Colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy treatment
Arm Type
Experimental
Arm Description
Chemotherapy treatment with Xelox or Xeliri and bevacizumab
Intervention Type
Drug
Intervention Name(s)
Xelox or Xeliri Bevacizumab
Other Intervention Name(s)
Cytokines measure, Angiogenic study
Intervention Description
Chemotherapy treatment
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Days from cycle one day one to progression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Feasibility
Description
Feasibility of doing a clinical prospective trial with a measure od plasma citoquines.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually Patients with bone disease as the only manifestation of the disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cubillo, MD PhaD
Organizational Affiliation
Grupo Hospital de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Integral oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

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Angiogenic Switch in Patients With Colorectal Cancer

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