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Clinical Trials/EUCTR2006-001371-38-SI
EUCTR2006-001371-38-SI
Active, not recruiting
Not Applicable

Cetuximab (Erbitux®), capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer: A phase II Pilot Study

Institute of Oncology Ljubljana0 sitesAugust 21, 2006
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DrugsErbitux

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Institute of Oncology Ljubljana
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 21, 2006
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Age 18 to 80 if judged fit for surgery.
  • •\- WHO peformance status 0\-1\.
  • •\- Histologically proven rectal adenocarcinoma located below the peritoneum.
  • •\- T3\-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI.
  • •\- No distant metastases.
  • •\- Adequate haematological, cardiac, liver and renal function.
  • •\- Signed infomed consent.
  • •\- Appropriate measures for contraception for men and women, if applicable.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •\- Prior radio\- and/or chemotherapy.
  • •\- Others synchronous cancers.
  • •\- History of other malignant disease.
  • •\- Significant heart disease.
  • •\- Known hypersensitivity to biological drugs.
  • •\- Pregnant or lactating patient.

Outcomes

Primary Outcomes

Not specified

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