Informations générales (source: ClinicalTrials.gov)
Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI) (RCMIGI)
Interventional
N/A
Institut du Cancer de Montpellier - Val d'Aurelle (Voir sur ClinicalTrials)
août 2016
décembre 2028
05 avril 2025
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology
using electromagnetic transponders implanted within the prostate. It is a real-time
target tracking system that takes into account both inter- and intrafractional target
motion. So the exact position and movement of the prostate can be determined during
radiation therapy treatment.
The aim of this study is to assess pelvic late toxicity rate after intensity-modulated
radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins.
In this randomized study, patients will receive IGRT treatment using the Calypso system
or a conventional IGRT treatment.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut regional du Cancer - Val d Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Localized prostate cancer, histologically proven.
- No evidence of metastases (M0). No evidence of lymph nodes involvement (N0)
(bilateral lymph node dissection is not mandatory if lymph node involvement risk is
low according to the Partin tables).
- Low-risk or intermediate clinical stage according to the D'Amico classification
(T1-T2 and Gleason < 8 and PSA < 20 ng/ml) (appendix 3).
- No grade > 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03
scale.
- Performance status ECOG ≤ 1.
- No hip prosthesis or metallic vascular graft near the prostate.
- No endopenian stent.
- No pace maker, implanted defibrillator or neurostimulator.
- No allergy to local anesthetics.
- No irreversible anticoagulation or antiplatelet treatment for the implantation
period.
- Pelvic and abdominal anatomy compatible with the use of the Calypso® system
(predictive detector to fiducials distance less than 19 cm, evaluated on planning
CT-scan) (distance from skin surface to prostate center less than 17 cm).
- Patient aged ≥ 18 and less than 80 years old.
- Dated and signed written informed consent available.
- Patients must be affiliated to a French Social Security System.
- Localized prostate cancer, histologically proven.
- No evidence of metastases (M0). No evidence of lymph nodes involvement (N0)
(bilateral lymph node dissection is not mandatory if lymph node involvement risk is
low according to the Partin tables).
- Low-risk or intermediate clinical stage according to the D'Amico classification
(T1-T2 and Gleason < 8 and PSA < 20 ng/ml) (appendix 3).
- No grade > 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03
scale.
- Performance status ECOG ≤ 1.
- No hip prosthesis or metallic vascular graft near the prostate.
- No endopenian stent.
- No pace maker, implanted defibrillator or neurostimulator.
- No allergy to local anesthetics.
- No irreversible anticoagulation or antiplatelet treatment for the implantation
period.
- Pelvic and abdominal anatomy compatible with the use of the Calypso® system
(predictive detector to fiducials distance less than 19 cm, evaluated on planning
CT-scan) (distance from skin surface to prostate center less than 17 cm).
- Patient aged ≥ 18 and less than 80 years old.
- Dated and signed written informed consent available.
- Patients must be affiliated to a French Social Security System.
- Indication of pelvic nodes irradiation.
- Prior pelvic irradiation.
- Biopsy-proven seminal vesicle invasion.
- Prior bilateral orchiectomy.
- Prior radical prostatectomy.
- Other malignancy except adequately-treated basal cell carcinoma of the skin or other
malignancy from which the patient has been disease-free for at least 5 years.
- Psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those
conditions should be discussed with the patient before registration in the trial.
- Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary
embolism, etc.).
- Known VIH positive patients (no specific test needed).
- Known homozygote ATM Mutation (Ataxia telengiectasia).