EUCTR2007-001987-55-ES
Active, not recruiting
Not Applicable
A randomised trial assessing whether preoperative chemotherapy improves outcome in high-risk operable colon cancer - FOxTROT
ConditionsPatients with high-risk, operable colon cancerMedDRA version: 18.0Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with high-risk, operable colon cancer
- Sponsor
- niversity Of Birmingham
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer
- •\- A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
- •Either radiological high risk (rT4 or rT3 tumour with extramural extension ? 5mm)
- •Or radiological intermediate risk (rT3 tumour with \<5mm extramural extension) and younger age/good general health
- •\- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
- •\- Adequate full blood count: WBC \>3\.0 x109/l; Plts \>100 x109/l. Anaemia (Hb \< 10\.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy
- •\- Adequate renal biochemistry: GFR \>50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance \>70 ml/min
- •\- Adequate hepatobiliary function: bilirubin \< 25 ?mol/l
- •\- Aged 18 or over
- •\- WHO performance status of 0, 1 or 2
Exclusion Criteria
- •\- Any patient for whom radiotherapy is advised by the MDT
- •\- Strong evidence of distant metastases or peritoneal nodules (M1\)
- •\- Peritonitis (secondary to perforated tumour)
- •\- Colonic obstruction that has not been defunctioned
- •\- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (\<6 months) MI
- •\- Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
- •\- Any other malignant disease within the preceding 5 years with the exception of non\-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \<5%
Outcomes
Primary Outcomes
Not specified
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