Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy
Evaluation of the Use of Non-invasive 4D Ultrasound Clarity System in Real-time Tracking of the Target Volume in Prostate IMRT/RapidArc Therapy
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).
In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.
Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Singapore, Singapore, 169610
- National Cancer Centre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria:
- Patient who cannot abide to the departmental hydration protocol
- Prostatectomy cases
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.
- Patient enrolled in other clinical trials
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The 3D ultrasound capability of the Clarity® system (from Elekta AB Stockholm, Sweden) in providing real-time information of the prostate movement during the treatment delivery
Tidsramme: 2 years
|
2 years
|
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The efficacy of full bladder protocol for patient undergoing prostate radiotherapy
Tidsramme: 2 years
|
2 years
|
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The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy
Tidsramme: 2 years
|
2 years
|
|
Patient comfort, compliance and tolerance of two setup techniques
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jeffrey Kit Long Tuan, Dr, National Cancer Centre, Singapore
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCC DRO 4D-us CS
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