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Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer (GERICO)

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ClinicalTrials.gov Identifier: NCT02748811
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Cecilia Lund, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 22, 2016
Last Update Posted Date May 23, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Number of patients completing planned treatment without dose reductions [ Time Frame: 12 month after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02748811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • Occurrence of dose reductions [ Time Frame: 1 month after end of treatment ]
    Data will be collected by reviewing patients medical charts
  • delay of treatment [ Time Frame: 1 month after end of treatment ]
    Data will be collected by reviewing patients medical charts
  • Adverse events to treatment [ Time Frame: 1 month after end of treatment ]
    Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.
  • time to recurrence [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Survival [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Cancer specific mortality [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Quality of Life prior [ Time Frame: at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months. ]
    Quality of life questionnaires will be filled out by the participants
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
  • Occurrence of dose reductions [ Time Frame: 1 month after end of treatment ]
    Data will be collected by reviewing patients medical charts
  • delay of treatment [ Time Frame: 1 month after end of treatment ]
    Data will be collected by reviewing patients medical charts
  • toxicity [ Time Frame: 1 month after end of treatment ]
    Data will be collected by reviewing patients medical charts
  • time to recurrence [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Survival [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Cancer specific mortality [ Time Frame: up to 80 months ]
    Data will be collected by reviewing patients medical charts
  • Quality of Life prior [ Time Frame: at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months. ]
    Quality of life questionnaires will be filled out by the participants
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Official Title  ICMJE Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer
Brief Summary

GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy.

The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Other: Intervention group
The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. The participants will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
Other Name: Comprehensive geriatric assessement and intervention
Study Arms  ICMJE
  • No Intervention: Control group
    The control group receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change in treatment or progression. If the patient has other health problems, those issues will be assessed either by the oncologist or by the general practitioner. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
  • Active Comparator: Intervention group
    The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. They will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
    Intervention: Other: Intervention group
Publications * Lund CM, Vistisen KK, Dehlendorff C, Rønholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer: a randomized trial (GERICO). BMC Cancer. 2017 Jun 28;17(1):448. doi: 10.1186/s12885-017-3445-8.

*   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: April 21, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Frail according to the screening tool G8 ( ≤14 / 17points)
  • Performance status 0-2 and life expectancy ≥ 3 months
  • Patients who have undergone surgery for stage III / high-risk stage II colorectal cancer or patients with unresectable or metastatic disease
  • Are assessed to receive adjuvant chemotherapy or first -line chemotherapy
  • Meets the criteria to receive preventive chemotherapy with 5-FU or capecitabine +/- oxaliplatin or first -line chemotherapy with 5-FU / irinotecan and / or oxaliplatin , capecitabine +/- possibly with the addition of immunotherapy in the form of cetuximab , panitumumab or bevacizumab.
  • Informed written and oral consent

Exclusion Criteria:

  • Other malignancy except basal cell carcinoma and squamous cell carcinoma in situ cervicis uteri in 5 years
  • Patients in simultaneously drug trials
  • The patient must not have previously received adjuvant chemotherapy in the GERICO Protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cecilia M Lund, MD 0045 3868 6112 cecilia.m.lund@gmail.com
Contact: Dorte Nielsen, Prof. DMSc. 0045 3868 2344 Dorte.Nielsen.01@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02748811
Other Study ID Numbers  ICMJE GERICO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cecilia Lund, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Danish Cancer Society
Investigators  ICMJE
Principal Investigator: Cecilia M Lund, MD Department of Oncology
PRS Account University of Copenhagen
Verification Date May 2018

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