- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01589939
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System (PTV)
Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Washington
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Tacoma, Washington, États-Unis, 98431
- Madigan Healthcare System
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1
- Signed informed consent
Exclusion Criteria:
- Node positive or metastatic prostate cancer
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of HIV infection
- History of chronic prostatitis or chronic cystitis
- History of bleeding disorder or any active anticoagulation (excluding ASA)
- PT or INR outside normal range for institution
- Active implanted devices such as cardiac pacemakers and automatic defibrillators.
- Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
- Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 8).
- Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
Délai: Approximately 8.5 weeks (43 fractions per pt.)
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During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
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Approximately 8.5 weeks (43 fractions per pt.)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Analyze dosimetric characteristics of treatment planning
Délai: usually within the first 2 weeks after beacon placement (done at simulation CT)
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Standard methods vs. reduced planning target volume expansions will be analyzed:
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usually within the first 2 weeks after beacon placement (done at simulation CT)
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Assess incidence of acute bladder and rectal toxicity
Délai: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
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toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
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approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
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Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- W81XWH-08-2-0174, A-15214.1a
- 207111 (Autre identifiant: Madigan Army IRB)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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