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Can seniors handle colon cancer chemo? new study aims to find out

NCT ID NCT02978612

Disease control Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at how well patients aged 75 and older tolerate chemotherapy after surgery for stage III colon cancer. Researchers measured changes in daily living activities and used geriatric assessments and gene tests to predict outcomes. The goal is to better identify which older patients can benefit from chemotherapy without major loss of function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Capecitabine (Xeloda) chemotherapy
What this could lead to
If successful, this could help doctors decide which elderly patients can safely receive chemotherapy after colon cancer surgery without major loss of independence.
What could go wrong
This is a small Phase 2 study, so results may not apply to all patients. Chemotherapy can cause side effects like fatigue, nausea, and increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2016

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) * 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. 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 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

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm colorectal neoplasm malignant colon neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon cancer

Contacts and locations

Locations

  • Oslo University Hospital

    Oslo, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.