Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer (GERICO)
24. september 2019 oppdatert av: Cecilia Lund, University of Copenhagen
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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Danmark
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Herlev, Danmark, Danmark, 2730
- Department of Oncology. Herlev and Gentofte Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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.
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Aktiv komparator: 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of patients completing planned treatment without dose reductions
Tidsramme: 12 month after randomization
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12 month after randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Occurrence of dose reductions
Tidsramme: 1 month after end of treatment
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Data will be collected by reviewing patients medical charts
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1 month after end of treatment
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delay of treatment
Tidsramme: 1 month after end of treatment
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Data will be collected by reviewing patients medical charts
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1 month after end of treatment
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Adverse events to treatment
Tidsramme: 1 month after end of treatment
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Adverse events will be registered for every cycle of treatment and assessed by an oncologist according to CTC- criteria version 4.0.
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1 month after end of treatment
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time to recurrence
Tidsramme: up to 80 months
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Data will be collected by reviewing patients medical charts
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up to 80 months
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Survival
Tidsramme: up to 80 months
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Data will be collected by reviewing patients medical charts
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up to 80 months
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Cancer specific mortality
Tidsramme: up to 80 months
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Data will be collected by reviewing patients medical charts
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up to 80 months
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Quality of Life prior
Tidsramme: at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.
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Quality of life questionnaires will be filled out by the participants
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at 0 months and after 2 months and at the end of the treatment;e.g. up to 12months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cecilia M Lund, MD, Department of Oncology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Lund CM, Vistisen KK, Olsen AP, Bardal P, Schultz M, Dolin TG, Ronholt F, Johansen JS, Nielsen DL. The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO). Br J Cancer. 2021 Jun;124(12):1949-1958. doi: 10.1038/s41416-021-01367-0. Epub 2021 Apr 7.
- Lund CM, Vistisen KK, Dehlendorff C, Ronholt 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2015
Primær fullføring (Faktiske)
1. september 2019
Studiet fullført (Faktiske)
1. september 2019
Datoer for studieregistrering
Først innsendt
31. mars 2016
Først innsendt som oppfylte QC-kriteriene
21. april 2016
Først lagt ut (Anslag)
22. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GERICO
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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