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Trial record 7 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

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

This study is currently recruiting participants.
Verified May 2017 by Cecilia Lund, University of Copenhagen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748811
First Posted: April 22, 2016
Last Update Posted: May 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Cecilia Lund, University of Copenhagen
  Purpose

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.


Condition Intervention
Colorectal Neoplasms Other: Intervention group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Cecilia Lund, University of Copenhagen:

Primary Outcome Measures:
  • Number of patients completing planned treatment without dose reductions [ Time Frame: 12 month after randomization ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: May 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02748811


Contacts
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

Locations
Denmark
Department of Oncology. Herlev and Gentofte Hospital Recruiting
Herlev, Danmark, Denmark, 2730
Contact: Cecilia M Lund, MD    60141841    cecilia.m.lund@gmail.com   
Sponsors and Collaborators
University of Copenhagen
Danish Cancer Society
Investigators
Principal Investigator: Cecilia M Lund, MD Department of Oncology
  More Information

Responsible Party: Cecilia Lund, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02748811     History of Changes
Other Study ID Numbers: GERICO
First Submitted: March 31, 2016
First Posted: April 22, 2016
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cecilia Lund, University of Copenhagen:
elderly
intervention study
geriatrics
chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases