NCT02978612CompletedPhase 2
Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III
Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
This is a phase 2, randomized study where the aim of the study is to investigate the tolerance of adjuvant chemotherapy, measured by functional decline, after surgery for colon cancer stage III in elderly patients. Secondary aims are disease-free survival, toxicity, late functional outcome, quality of life, to establish a geriatric assessment for selection of patients, and to examine the prognostic value of gene signature tests / biomarkers for stage III colon cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 15 Jun 2016
- Start date
- Jun 2016
- Primary completion date
- Nov 2022
- Lead sponsor
- Oslo University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT02978612
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 170
- From Jun 2016 to the primary completion date, Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with chemotherapy for colorectal cancer
- 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
Other illness
- Significant cardiovascular disease (congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within the past 12 months
- Metastatic disease from other cancer
- Adverse reactions or hypersensitivity to capecitabine or related drugs and/or its excipients. Need to use medications contraindicated according to SmPC of the IMP(s), such as sorivudine, brivudin or chemically related compounds. Any other contraindication listed on the summary of product characteristics (SmPC) of the investigational medicinal Product (IMP)
- 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
Other
- Distant metastases (stage IV)
- Frail according to geriatric assessment
- Reduced cognitive function not enabling ability to give informed consent or compliance with the study
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any reason why, in the opinion of the investigator, the patient should not participate
Who the study is looking for
- 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)
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH GCP) and national regulations.
Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.