| TITRE |
(EN) A Pilot Study of Dose-escalation Strategy of Radiotherapy Followed by Endorectal Brachytherapy With the Use of a New Rectal Applicator in Inoperable, Ederly Rectal Cancer Patients |
| PROTOCOLE ID |
Whistle |
| CLINICAL TRIAL.gov ID |
NCT04336202 |
| TYPE(S) DE CANCER |
Colorectal |
| PHASE |
|
| TYPE D'ÉTUDE |
Autre |
| INSTITUTION |
HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Té Vuong
|
| COORDONATEUR(RICE) |
Luciana Poggi
luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 28443
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Patients with histologic diagnosis by proctoscopic biopsy of invasive rectal adenocarcinoma will be considered for entry in this study.
- Patient in whom the diagnosis of invasive rectal cancer has been obtained by incisional biopsy (surgical or endoscopic biopsy) that the majority of the tumor has not been removed .
- The tumor should be either palpable by clinical rectal exam or accessible via a rigid proctoscope, and its proximal border should be located no more than 15 cm from the anal verge.
- Rectal cancer clinically stage as T2-T3 N1+ by MRI or endoscopic ultrasound.
- Tumor of 5 cm or less length, non obstructive
- Patient is not suitable for surgery nor chemotherapy due to medical conditions
- Patient must consent to be in the study and consent form must be signed, witnessed and dated prior to registration .
- Patients must be accessible geographically for follow up.
- Adults older than 18 years of age
|
| CRITÈRES D'EXCLUSION |
(EN)
- Patient with malignant rectal tumors other than adenocarcinoma, i.e, sarcoma, lymphoma, carcinoid, squamous cell, cloacogenic, etc.
- Patient who demonstrate prior to randomization, evidence of free perforation, as manifested by free fluid in the abdomen.
- Patient who are curable by standard of care with either surgery or eligible for the Morpheus study.
- Patient who have received any previous therapy (radiation , chemotherapy) for rectal cancer.
- Patient whose tumor is fixed by clinical examination to surrounding structures, precluding the possibility of adequate surgical resection even with pelvic exenteration.
- Patient with a performance status of 3 or 4.
- Patient with tumor involving the anal canal.
- Patient who are pregnant at the time of randomization.
- Patient with psychiatric or addictive disorders that would preclude obtaining informed consent.
- Patient who have multiple primary tumors involving both the colon and rectum that would preclude them from being classified as having only rectal cancer.
|
