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Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer


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

Thank you

Trial Information

Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer


Inclusion Criteria:



- Histologically or cytologically proven colorectal cancer

- Unresectable stage IV disease

- K-Ras wild type tumour

- Patients scheduled to undergo chemotherapy with irinotecan and cetuximab

Exclusion Criteria:

- Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to
inclusion in the study

- Poorly controlled diabetes

- Concomitant serious illness, such as uncontrolled angina pectoris, myocardial
infarction, heart failure, uncontrolled hypertension, infection

- Symptomatic brain metastases

- Pregnancy or participants of reproductive potential who are sexually active and not
willing/able to use medically appropriate contraception

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

PET response on day 7

Outcome Time Frame:

day 7

Safety Issue:

No

Principal Investigator

Eric Van Cutsem, Prof.Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

UZ Leuven

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

s51276 - ML5241

NCT ID:

NCT00828620

Start Date:

January 2009

Completion Date:

June 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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