Study to assess the preoperative chemotherapy in colon cancer

• Conditions: Patients with high-risk, operable colon cancer; MedDRA 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]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-14
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1050

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
- If female and of childbearing potential, must:
Have a negative pregnancy test ?72hours prior to initiating study treatment
Agree to avoid pregnancy during and for 6 months after study treatment
- If male with a partner of childbearing potential, must:
Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
- Patient 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 1020
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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%

Study & Design

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