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

Institute of Oncology Ljubljana

Status and phase

Unknown

Phase 2

Conditions

Rectal Cancer

Treatments

Drug: cetuximab, capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00689702

EMR 62202-688

Details and patient eligibility

About

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.

Full description

Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.

Enrollment

43 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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