UnknownPhase 2

Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer

Slovenia43 participantsStarted 2007-02

Plain-language summary

This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 80 if judged fit for surgery * WHO performance 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 informed consent * Appropriate measures for contraception for men and women, if applicable 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

What they're measuring

Complete pathological remission rate

Timeframe: at pathological examm of surgical speciment

Trial details

NCT IDNCT00689702

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-04

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