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Trial record 1 of 1 for:    Adjuvant chemotherapy in elderly with colon cancer stage III - geriatric assessment and prognostic gene signatures
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Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III (ACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978612
Recruitment Status : Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Marianne Grønlie Guren, Oslo University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Capecitabine Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures
Study Start Date : June 2016
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm Capecitabine
Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles
 Drug: Capecitabine
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
Other Name: Xeloda
No Intervention: Arm No treatment
no chemotherapy, observation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives [ Time Frame: through study completion ]
    Number of planned chemotherapy cycles given, total dose given

  2. Toxicity of chemotherapy [ Time Frame: During treatment and follow-up 1 year after surgery ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3. Disease-free survival [ Time Frame: 3 years after surgery ]
    Follow-up, 3-year disease-free survival

  4. Quality of life questionnaire 1 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EQ-5D-5L

  5. Quality of life questionnaire 2 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EORTC QLQ-C30

  6. Quality of life questionnaire 3 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    QLQ-ELD14

  7. Validation of the performance of prognostic biomarkers in estimating disease-free survival [ Time Frame: 3 years after surgery ]
    Prognostic biomarkers validated for performance in estimating 3-year disease-free survival

  8. Overall survival [ Time Frame: 5 years after surgery ]
    Follow-up, 5-year disease-free survival


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978612


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Marianne G Guren, MD, PhD Oslo University Hospital
More Information
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Responsible Party: Marianne Grønlie Guren, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02978612    
Other Study ID Numbers: 2015/1252
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marianne Grønlie Guren, Oslo University Hospital:
Colorectal Neoplasms
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents