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Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathological remission rate

Outcome Time Frame:

at pathological examm of surgical speciment

Safety Issue:

No

Principal Investigator

Vaneja Velenik, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Oncology, Ljubljana, Slovenia

Authority:

Slovenia: Agency for Medicinal Products - Ministry of Health

Study ID:

EMR 62202-688

NCT ID:

NCT00689702

Start Date:

February 2007

Completion Date:

May 2013

Related Keywords:

  • Rectal Cancer
  • cetuximab
  • capecitabine
  • radiotherapy
  • rectal cancer
  • Rectal Neoplasms

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