ADJUVANT CHEMOTHERAPY IN ELDERLY CRC– ACE Study

Phase 1

• Conditions: undergone R0-resection of for colon cancer stage III; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002701-11-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-06
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

·Radical surgery (R0/R1) for colon cancer
·Histologically verified adenocarcinoma of the colon
·Histologically verified lymph node metastases (Stage III)
·Age = 75 years
·Able to undergo ambulatory treatment (adequate physical and mental function)
·Lab values as the following:
- absolute neutrophil count ³1.5 x 109/L
- platelet count ³100 x 109/L
- clinically acceptable haemoglobin levels
- creatinine levels indicating renal clearance of ³30 ml/min
- bilirubin =1.5 x UNL (upper normal limit)
·Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP and national regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

·Distant metastases (stage IV)
·Frail according to geriatric assessment
·Significant cardiovascular disease (congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within the past 12 months
·Previous treatment with chemotherapy for colorectal cancer
·Metastatic disease from other cancer
·Reduced cognitive function not enabling ability to give informed consent or compliance with the study
·History of prior or concurrent malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix
·Adverse reactions to capecitabine or related drugs. Need to use medications contraindicated according to SmPC of the IMP(s), such as sorivudin, brivudin or chemically related compounds. Any other contraindication listed on the SmPC of the IMP(s)
·Use of methotrexate or other cytotoxic drugs as treatment of rheumatoid arthritis or other inflammatory disease and where it is considered contraindicated to stop this medication
·Known DPD deficiency
·Any reason why, in the opinion of the investigator, the patient should not participate

Study & Design

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