Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02978612
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional decline in instrumental activities of daily living (IADL) and/or activities of daily living (ADL)', 'timeFrame': '1 year after surgery', 'description': 'Tolerance of adjuvant chemotherapy in elderly patients, measured as functional decline or independency, by ADL and IADL questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives', 'timeFrame': 'through study completion', 'description': 'Number of planned chemotherapy cycles given, total dose given'}, {'measure': 'Toxicity of chemotherapy', 'timeFrame': 'During treatment and follow-up 1 year after surgery', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years after surgery', 'description': 'Follow-up, 3-year disease-free survival'}, {'measure': 'Quality of life questionnaire 1', 'timeFrame': 'Time of randomization, 6 months and 1 year after surgery', 'description': 'EQ-5D-5L'}, {'measure': 'Quality of life questionnaire 2', 'timeFrame': 'Time of randomization, 6 months and 1 year after surgery', 'description': 'EORTC QLQ-C30'}, {'measure': 'Quality of life questionnaire 3', 'timeFrame': 'Time of randomization, 6 months and 1 year after surgery', 'description': 'QLQ-ELD14'}, {'measure': 'Validation of the performance of prognostic biomarkers in estimating disease-free survival', 'timeFrame': '3 years after surgery', 'description': 'Prognostic biomarkers validated for performance in estimating 3-year disease-free survival'}, {'measure': 'Overall survival', 'timeFrame': '5 years after surgery', 'description': 'Follow-up, 5-year disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal Neoplasms'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radical surgery (R0/R1) for colon cancer\n* Histologically verified adenocarcinoma of the colon\n* Histologically verified lymph node metastases (Stage III)\n* Age ≥ 75 years\n* Able to undergo ambulatory treatment (adequate physical and mental function)\n* 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.\n\nExclusion Criteria:\n\n* Distant metastases (stage IV)\n* Frail according to geriatric assessment\n* Significant cardiovascular disease (congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia) or myocardial infarction within the past 12 months\n* Previous treatment with chemotherapy for colorectal cancer\n* Metastatic disease from other cancer\n* Reduced cognitive function not enabling ability to give informed consent or compliance with the study\n* 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\n* 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)\n* 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\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency\n* Any reason why, in the opinion of the investigator, the patient should not participate'}, 'identificationModule': {'nctId': 'NCT02978612', 'acronym': 'ACE', 'briefTitle': 'Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures', 'orgStudyIdInfo': {'id': '2015/1252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm Capecitabine', 'description': 'Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles', 'interventionNames': ['Drug: Capecitabine']}, {'type': 'NO_INTERVENTION', 'label': 'Arm No treatment', 'description': 'no chemotherapy, observation'}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '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', 'armGroupLabels': ['Arm Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Marianne G Guren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Marianne Grønlie Guren', 'investigatorAffiliation': 'Oslo University Hospital'}}}}