Know Cancer

or
forgot password

A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metastases


Inclusion Criteria:



- Primary colorectal cancer with unresectable metastatic lesion(s)

- At least one measurable lesion, confirmed by CT scan

- Male and female patients, aged ≥ 18 years

- ECOG performance score of 0 or 1 (within 1 week of study treatment start)

- Written informed consent

- Adequate general condition, cardiopulmonary functions and performance status

- Liver metastases no initially foreseen R0 resection of all hepatic lesions, but
deemed potentially resectable after response to downsizing therapy

Exclusion Criteria:

- Extrahepatic metastatic disease

- Prior systemic or local treatment for metastatic disease, prior therapy with a
biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to
the liver, other concurrent chemotherapy

- Inadequate bone marrow, liver, renal function, uncontrolled hypertension

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer

Outcome Time Frame:

after 8 IXO+A cycles

Safety Issue:

No

Principal Investigator

Jean Maroun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Ottawa Hospital Cancer Centre

Authority:

Canada: Health Canada

Study ID:

OTT 10-01

NCT ID:

NCT01293942

Start Date:

March 2011

Completion Date:

February 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • unresectable liver-only metastases in colorectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location