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Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III (ACE)

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ClinicalTrials.gov Identifier: NCT02978612
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Marianne Grønlie Guren, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE December 1, 2016
Last Update Posted Date August 30, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02978612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • 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
  • 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
  • Disease-free survival [ Time Frame: 3 years after surgery ]
    Follow-up, 3-year disease-free survival
  • Quality of life questionnaire 1 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EQ-5D-5L
  • Quality of life questionnaire 2 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EORTC QLQ-C30
  • Quality of life questionnaire 3 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    QLQ-ELD14
  • 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
  • Overall survival [ Time Frame: 5 years after surgery ]
    Follow-up, 5-year disease-free survival
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Relative dose intensity; i.e the percentage of planned chemotherapy dose the patient actually receives [ Time Frame: During treatment ]
    Number of planned chemotherapy cycles given, total dose given
  • 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
  • Disease-free survival [ Time Frame: 3 years after surgery ]
    Follow-up, 3-year disease-free survival
  • Quality of life questionnaire 1 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EQ-5D-5L
  • Quality of life questionnaire 2 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    EORTC QLQ-C30
  • Quality of life questionnaire 3 [ Time Frame: Time of randomization, 6 months and 1 year after surgery ]
    QLQ-ELD14
  • 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
  • Overall survival [ Time Frame: 5 years after surgery ]
    Follow-up, 5-year disease-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III
Official Title  ICMJE Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Arm Capecitabine
    Capecitabine 1000 mg/m2 bid day 1-14 q3 weeks, 8 cycles
    Intervention: Drug: Capecitabine
  • No Intervention: Arm No treatment
    no chemotherapy, observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2032
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marianne G Guren, MD, PhD marianne.gronlie.guren@ous-hf.no
Contact: Morten Brændengen, MD, PhD morten.braendengen@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978612
Other Study ID Numbers  ICMJE 2015/1252
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marianne Grønlie Guren, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marianne G Guren, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP