- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02257827
Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule
Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Sao Paulo
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Marilia, Sao Paulo, Brésil
- Faculty of Medicine of Marilia
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with diagnosis of prostate cancer
- With age between 18-75 years classified in low
- Intermediate and high-risk group according to their Gleason score
- T stage and initial PSA (iPSA).
- Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL.
- Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
- High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL.
- All patients classified as high risk was submitted to the bone scans.
Exclusion Criteria:
- Patients with metastases
- Prior history of prostatectomy
- Pelvic radiotherapy treatment
- Chemotherapy treatment were excluded of this trial.
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 |
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Expérimental: IMRT- Hypofractionated schedule 70 Gy/25 fx
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy.
All patients were simulated on CT simulator.
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The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV. The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
Autres noms:
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Comparateur actif: 3DCRT-Hypofractionated schedule 70 Gy/25 fx
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy.
All patients were simulated on CT simulator.
|
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV. The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Gastrointestinal and geniturinary acute toxicity
Délai: 6 months
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The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment.
Patients were seen weekly, or as required, during treatment by a radiation oncologist.
Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
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6 months
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Gastrointestinal and geniturinary late toxicity
Délai: 24 months
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Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity.
Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
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24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Biochemical control
Délai: 3 years
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The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.
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3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gustavo Viani, PhD, FAMEMA
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FAMEMA-0913
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 .
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