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Clinical Trials/EUCTR2011-005003-32-NL
EUCTR2011-005003-32-NL
Active, not recruiting
Phase 1

A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone.

VU University Medical Center, Department of Medical Oncology0 sites478 target enrollmentMarch 5, 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
multi-organ metastatic colorectal cancer
Sponsor
VU University Medical Center, Department of Medical Oncology
Enrollment
478
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VU University Medical Center, Department of Medical Oncology

Eligibility Criteria

Inclusion Criteria

  • Patients with indication for first line palliative systemic treatment for metatastatic colorectal cancer, with CRC metastases in \= 2 different organs, minimum age 18 years, life expectancy of at least 12 weeks
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 239
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 239

Exclusion Criteria

  • Prior (neo\-)adjuvant chemotherapy \< 6 months after last treatment and first detection of metastasis (except for neoadjuvant capecitabin in the context of chemoradiation for rectal carcinoma), candidates for HIPEC, evidence of brain metastases, history of cardiac disease, uncontrolled hypertension, uncontrolled infections, pregnancy or breast feeding

Outcomes

Primary Outcomes

Not specified

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