Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
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| ClinicalTrials.gov Identifier: NCT03254420 |
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Recruitment Status :
Active, not recruiting
First Posted : August 18, 2017
Last Update Posted : November 30, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Device: Calypso beacon implant Radiation: moderate hypofractionation Radiotherapy | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI) |
| Actual Study Start Date : | August 30, 2016 |
| Estimated Primary Completion Date : | December 2028 |
| Estimated Study Completion Date : | December 2028 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Image-guided radiation therapy (IGRT) with standard margins
moderate hypofractionation during 4 weeks
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Radiation: moderate hypofractionation Radiotherapy
moderate hypofractionation Radiotherapy |
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Experimental: Calypso tracking system with margin reduction
moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
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Device: Calypso beacon implant
Calypso beacon implant before radiotherapy Radiation: moderate hypofractionation Radiotherapy moderate hypofractionation Radiotherapy |
- assessment of grade > 2 late pelvic toxicities [ Time Frame: up to 2 years post treatment ]assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254420
| France | |
| Institut regional du Cancer - Val d Aurelle | |
| Montpellier, France, 34298 | |
| Study Chair: | Riou Olivier | Institut régional du Cancer de Montpellier |
| Responsible Party: | Institut du Cancer de Montpellier - Val d'Aurelle |
| ClinicalTrials.gov Identifier: | NCT03254420 |
| Other Study ID Numbers: |
ICM-URC2015/33 |
| First Posted: | August 18, 2017 Key Record Dates |
| Last Update Posted: | November 30, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |