Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
31 maggio 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
50
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- Radiation Oncology Clinic - UNC Cancer Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
65 anni e precedenti (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Bhishamjit Chera, MD, Radiation Oncology UNC Cancer Hospital
- Direttore dello studio: Noam VanderWalde, MD, Radiation Oncology UNC Cancer Hospital
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2012
Completamento primario (Effettivo)
1 marzo 2015
Completamento dello studio (Effettivo)
1 marzo 2015
Date di iscrizione allo studio
Primo inviato
14 dicembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
18 dicembre 2012
Primo Inserito (Stima)
19 dicembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 maggio 2018
Ultimo verificato
1 maggio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- LCCC 1224
- 1224 (Altro numero di sovvenzione/finanziamento: Lineberger Cancer Center)
- 121731 (Altro identificatore: UNC IRB)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .