Clinical Trials /

Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.

NCT03254420

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.
  • Official Title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

Clinical Trial IDs

  • ORG STUDY ID: ICM-URC2015/33
  • NCT ID: NCT03254420

Conditions

  • Prostate Cancer

Purpose

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.

Detailed Description

      Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference
      treatments for localized prostate cancer. Prostate was initially thought to be a non-moving
      target, but the newest reports have raised the contrary as evidence. Image-guided
      radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which
      enables to take into account interfractional prostate motion before treatment.

      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.

      As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ
      motion, margin reduction can reasonably be considered in case of target motion management
      improvement.

      To date, no prospective randomized clinical data is available using this technique for the
      treatment of low- or intermediate-risk prostate cancer patients with modern standard
      fractionation radiotherapy and image guidance.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Image-guided radiation therapy (IGRT) with standard marginsActive ComparatorStandard IMRT during 8 weeks
    Calypso tracking system with margin reductionExperimentalStandard IMRT during 8 weeks after calypso beacon implant 10 days before

      Eligibility Criteria

              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.
      
              Exclusion Criteria:
      
                -  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).
            
      Maximum Eligible Age:80 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:assessment of grade > 2 late pelvic toxicities
      Time Frame:up to 2 years post treatment
      Safety Issue:
      Description:assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Institut du Cancer de Montpellier - Val d'Aurelle

      Last Updated