Colon CancerPhase 2ACENCT02978612
Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III
A Phase 2 study testing Capecitabine in people with Colon Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2016to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures
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.
Read the detailed description
Patients ≥ 75 years who have undergone surgery for colon cancer stage III, are eligible for inclusion in the study. Non-eligibility includes patients with obvious impaired cognitive or physical function or patients living in nursing homes. After signing informed consent, the patients first undergo geriatric assessment. Patients that are classified as having fit or intermediate function, and with no significant cardiovascular disease, are randomized with a 2:1 randomization process to either chemotherapy (Arm A: Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles) or no chemotherapy (Arm B: observation).
The purpose of this study is to examine the tolerability of chemotherapy in elderly (> 75 years) patients operated on for colon cancer stage III. There is little evidence of benefit and tolerability of this therapy in the elderly; it is recommended individual consideration in elderly. In the study, a comprehensive geriatric a comprehensive geriatric assessment is performed first, to exclude frail patients or patients with serious comorbidities such as cardiovascular disease. Fit or intermediate patients will then be randomized so that 2/3 will receive chemotherapy with capecitabine tablets for 6 months, and 1/3 will not receive chemotherapy. A new geriatric assessment is performed after 6 and 12 months. The main objective of the study is to examine whether chemotherapy leads to significant loss of function, but secondary aims include survival, quality of life, and prognostic effect of biomarkers. The study may provide useful information on selection of patients who tolerate and benefit from adjuvant chemotherapy.
- Conditions
- Colon Cancer
- Being tested
- Capecitabine
- Keywords
- Colorectal Neoplasms
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
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
| Study group | Role | What they receive |
|---|---|---|
| Arm Capecitabine | Experimental | Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles Receives: Drug: Capecitabine |
| Arm No treatment | No intervention | no chemotherapy, observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after surgery
Secondary outcomes (8)
Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives
Number of planned chemotherapy cycles given, total dose given
Measured: through study completion
Toxicity of chemotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: During treatment and follow-up 1 year after surgery
Disease-free survival
Follow-up, 3-year disease-free survival
Measured: 3 years after surgery
Quality of life questionnaire 1
EQ-5D-5L
Measured: Time of randomization, 6 months and 1 year after surgery
Quality of life questionnaire 2
EORTC QLQ-C30
Measured: Time of randomization, 6 months and 1 year after surgery
Quality of life questionnaire 3
QLQ-ELD14
Measured: Time of randomization, 6 months and 1 year after surgery
Validation of the performance of prognostic biomarkers in estimating disease-free survival
Prognostic biomarkers validated for performance in estimating 3-year disease-free survival
Measured: 3 years after surgery
Overall survival
Follow-up, 5-year disease-free survival
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2022
- Study completionJan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Grønlie Guren, Oslo University Hospital
- Investigators
- Marianne G Guren, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978612
- Sponsor's protocol ID
- 2015/1252
- Acronym
- ACE
- Status last verified
- Aug 2025
- First submitted
- 15 Jun 2016
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures
- ClinicalTrials.gov ID
- NCT02978612
- Acronym / sponsor ID
- ACE / 2015/1252
- Conditions
- Colon Cancer
- Keywords
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients ≥ 75 years who have undergone surgery for colon cancer stage III, are eligible for inclusion in the study. Non-eligibility includes patients with obvious impaired cognitive or physical function or patients living in nursing homes. After signing informed consent, the patients first undergo geriatric assessment. Patients that are classified as having fit or intermediate function, and with no significant cardiovascular disease, are randomized with a 2:1 randomization process to either chemotherapy (Arm A: Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles) or no chemotherapy (Arm B: observation).
The purpose of this study is to examine the tolerability of chemotherapy in elderly (> 75 years) patients operated on for colon cancer stage III. There is little evidence of benefit and tolerability of this therapy in the elderly; it is recommended individual consideration in elderly. In the study, a comprehensive geriatric a comprehensive geriatric assessment is performed first, to exclude frail patients or patients with serious comorbidities such as cardiovascular disease. Fit or intermediate patients will then be randomized so that 2/3 will receive chemotherapy with capecitabine tablets for 6 months, and 1/3 will not receive chemotherapy. A new geriatric assessment is performed after 6 and 12 months. The main objective of the study is to examine whether chemotherapy leads to significant loss of function, but secondary aims include survival, quality of life, and prognostic effect of biomarkers. The study may provide useful information on selection of patients who tolerate and benefit from adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Capecitabine | Experimental | Drug: CapecitabineCapecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles |
| Arm No treatment | No intervention | –no chemotherapy, observation |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaCapecitabine 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 | Drug | Arm Capecitabine |
Primary outcome
Functional decline in instrumental activities of daily living (IADL) and/or activities of daily living (ADL)
Time frame: 1 year after surgery
Tolerance of adjuvant chemotherapy in elderly patients, measured as functional decline or independency, by ADL and IADL questionnaires.
8 secondary outcomes
Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives
Time frame: through study completion
Toxicity of chemotherapy
Time frame: During treatment and follow-up 1 year after surgery
Disease-free survival
Time frame: 3 years after surgery
Quality of life questionnaire 1
Time frame: Time of randomization, 6 months and 1 year after surgery
Quality of life questionnaire 2
Time frame: Time of randomization, 6 months and 1 year after surgery
Quality of life questionnaire 3
Time frame: Time of randomization, 6 months and 1 year after surgery
Validation of the performance of prognostic biomarkers in estimating disease-free survival
Time frame: 3 years after surgery
Overall survival
Time frame: 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne G Guren, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Colon Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional decline in instrumental activities of daily living (IADL) and/or activities of daily living (ADL) (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.