XERXES: Examining the role of early neoadjuvant and synchronous Erbitux in pre-operative chemo-radiotherapy using Xeloda followed by excisional surgery. A phase I/II dose escalation study of intravenous erbitux (cetuximab) in combination with 5 day weekly oral Xeloda (capecitabine) and preoperative radiotherapy in rectal cancer. - XERXES

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001926-26-GB

Enrollment

Registered

2005-06-02

Start date

2005-06-10

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced rectal cancer

Interventions

Trade Name: Erbitux Product Name: Erbitux Product Code: n/a Pharmaceutical Form: Solution for infusion Product Name: Xeloda

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biopsy proven adenocarcinoma of the rectum (tumour =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent; Previous radiotherapy to the pelvis; Previous chemotherapy or radiation for rectal cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and toxicity of the combination of erbitux, capecitabine and radiotherapy. This will be determined through an assessment of the patient’s toxicity;Secondary Objective: To determine the efficacy of the treatment schedules. This will be determined through an evaluation of disease-free survival.;Primary end point(s): Acute Toxicity (grade 3 or above in defined Dose Limiting Toxicities)	—

Measure

Time frame

Main Objective: To evaluate the safety and toxicity of the combination of erbitux, capecitabine and radiotherapy. This will be determined through an assessment of the patient’s toxicity;Secondary Objective: To determine the efficacy of the treatment schedules. This will be determined through an evaluation of disease-free survival.;Primary end point(s): Acute Toxicity (grade 3 or above in defined Dose Limiting Toxicities)

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026