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Completed

NCT Number: NCT02748811

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology. Herlev and Gentofte Hospital

Herlev, Danmark, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group

Other

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 names: Comprehensive geriatric assessement and intervention

Primary outcomes

  1. Number of patients completing planned treatment without dose reductions

    Time frame: 12 month after randomization

Secondary outcomes

  1. Occurrence of dose reductions

    Time frame: 1 month after end of treatment

    Data will be collected by reviewing patients medical charts

  2. delay of treatment

    Time frame: 1 month after end of treatment

    Data will be collected by reviewing patients medical charts

  3. 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.

  4. time to recurrence

    Time frame: up to 80 months

    Data will be collected by reviewing patients medical charts

  5. Survival

    Time frame: up to 80 months

    Data will be collected by reviewing patients medical charts

  6. Cancer specific mortality

    Time frame: up to 80 months

    Data will be collected by reviewing patients medical charts

  7. 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danish Cancer Society

Registry information

Acronym: GERICO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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