Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer: A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high-risk operable colon cancer - FOxTROT

Phase 1

• Conditions: MedDRA version: 14.1Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Patients with high-risk, operable colon cancer; MedDRA version: 14.1Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-001987-55-SE
• Lead Sponsor: niversity Of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-18
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Histologically proven colon cancer with a radiological staging of greater than or equal to T3, NX, M0.
2.Patients who have been fully staged radiologically by CT scanning and are poor prognosis (ref to protocol for further info).
3.Fit for the neoadjuvant treatments; (details in protocol)
4.Patients who have presented with acute colonic obstruction may enter the trial only if a successful defunctioning or stent procedure has been performed.
5.Patients able and willing to provide written informed consent for the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with evidence of disseminated disease.
2. Patients with tumour with rectal cancer
3. Patients with peritonitis (secondary to perforated tumour)
4. Patients with obstruction, who are not defunctioned or stented.
5. Patients unable to give informed consent.
6. Patients with serious medical comorbidity
7. Patients with an indication for radiotherapy
8. Patients under the age of 18 or pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified