The Prostate Immobilization Device Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. This information was obtained using a conebeam CT scan on the treatment couch prior to a regularly scheduled radiation treatment. The conebeam CT scan is a standard tool for monitoring patient position and radiation treatment accuracy. Prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. On board portal imaging was then employed using the KvKv match technique to place isocenter as simulated. For intact prostate treatment, alignment was made to implanted gold fiducial markers. For post prostatectomy patients, the alignment was to pelvic bony anatomy. After patient alignment was complete, a conebeam CT scan was obtained. The position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. Measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. For post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. These measurements were recorded weekly by the treating radiation oncologist on the Physician Data Sheet.
The difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(unable to insert). These results were summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(intolerable). These responses will be summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Wisconsin
-
Racine, Wisconsin, États-Unis, 53405
- Wheaton Francsican Cancer Care - All Saints
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years of age or older
- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
- Planned definitive radiation therapy
Exclusion Criteria:
- Prior proctectomy
- Rectal surgery within one year
- Proctitis
- Rectal carcinoma
- Anal Stenosis
- History of inflammatory bowel disease
- Scleroderma
- Systemic sclerosis
- Refusal of treatment with immobilization device
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Miller enema air tip
The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy.
|
Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
Autres noms:
|
|
Comparateur actif: Radiadyne Immobilizer
The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy
|
Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
Délai: Up to 9 weeks
|
Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment.
An average value will be determined for each patient.
An average of individual patient values will be determined for each immobilization device.
|
Up to 9 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difficulty of Insertion.
Délai: Up to nine weeks
|
Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult).
An average score was obtained at completion of therapy for each patient.
At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
|
Up to nine weeks
|
|
Patient Expression of Discomfort
Délai: Up to nine weeks
|
Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable).
An average score was obtained at completion of therapy for each patient.
At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
|
Up to nine weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: James H Taylor, MD, Wheaton Franciscan Cancer Care - All Saints
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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 (Réel)
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
- 11-019-ASH
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .