Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
31. mai 2018 oppdatert av: UNC Lineberger Comprehensive Cancer Center
Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments.
The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1).
Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire.
The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.
Studietype
Observasjonsmessig
Registrering (Faktiske)
50
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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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- Radiation Oncology Clinic - UNC Cancer 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
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.
Beskrivelse
Inclusion Criteria:
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Exclusion Criteria:
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of EBRT at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Cancer Patients Age 65 or above
Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
Tidsramme: 4-8 weeks post-radiation therapy
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To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy
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4-8 weeks post-radiation therapy
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy
Tidsramme: 4-8 weeks post-radiation therapy
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To assess the association between pre-treatment loss of at least one I-ADL on the CGA and the occurrence of any patient-reported acute grade 3-5 toxicity from radiation therapy
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4-8 weeks post-radiation therapy
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Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures
Tidsramme: 4-8 weeks post radiation therapy
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To assess the association between pre-treatment loss of at least one I-ADL on the CGA and changes in QoL measures, as evaluated by the EORTC-QLQ-C30 throughout radiation therapy
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4-8 weeks post radiation therapy
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Comparison of physician and patient-reported acute grade 3-5 toxicities
Tidsramme: 4-8 weeks post-radiation therapy
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To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population.
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4-8 weeks post-radiation therapy
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Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy
Tidsramme: 4-8 weeks post-radiation therapy
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To assess the association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to and/or patient reported and physician reported acute grade 3-5 toxicity from radiation therapy
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4-8 weeks post-radiation therapy
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Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment
Tidsramme: 4-8 weeks post-radiation therapy
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To explore the association between baseline components of the CGA (other than I-ADL) and poor tolerance to or occurrence of any patient-reported acute grade 3-5 toxicity from radiation treatment.
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4-8 weeks post-radiation therapy
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bhishamjit Chera, MD, Radiation Oncology UNC Cancer Hospital
- Studieleder: Noam VanderWalde, MD, Radiation Oncology UNC Cancer Hospital
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.
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 (Faktiske)
1. november 2012
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
14. desember 2012
Først innsendt som oppfylte QC-kriteriene
18. desember 2012
Først lagt ut (Anslag)
19. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- LCCC 1224
- 1224 (Lineberger Cancer Center)
- 121731 (Annen identifikator: UNC IRB)
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