Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III

NCT02978612 | Completed Phase 2

• 1 other identifier: 2015/1252
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Functional decline in instrumental activities of daily living (IADL) and/or activities of daily living (ADL)

  Tolerance of adjuvant chemotherapy in elderly patients, measured as functional decline or independency, by ADL and IADL questionnaires.

  1 year after surgery

Secondary Outcomes (8)

• Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives

  through study completion

• Toxicity of chemotherapy

  During treatment and follow-up 1 year after surgery

• Disease-free survival

  3 years after surgery

• Quality of life questionnaire 1

  Time of randomization, 6 months and 1 year after surgery

• Quality of life questionnaire 2

  Time of randomization, 6 months and 1 year after surgery

Study Arms (2)

Arm Capecitabine

EXPERIMENTAL

Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles

Drug: Capecitabine

Arm No treatment

NO INTERVENTION

no chemotherapy, observation

Interventions

Capecitabine DRUG

Capecitabine is a prodrug to 5-fluorouracil. It is used for adjuvant chemotherapy after surgery for colon cancer. The tablets are either 150 mg or 500 mg

Also known as: Xeloda

Arm Capecitabine

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Marianne G Guren, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: December 1, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

NO (1)