RCMI PELVIS: Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers
Study Details
Study Description
Brief Summary
The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Medico-economic study : medical cost differential between 3 ways of Radiotherapy by IMRT (helical tomotherapy and dynamic arc therapy : RapidArc and VMAT). [2 months]
Costs of the devices, maintenance costs ; personnel costs directly related to the medical therapeutic procedure (physicians, medical physicists, dosimetry, technicians).
Secondary Outcome Measures
- Others economic criteria [2 months]
the estimation of the cost differential by individualizing the preparation phase and phase radiation the analysis of the possible impact of learning in helical tomotherapy and dynamic arc therapy with VMAT and RapidArc measured on direct costs (depending on the age of implantation and equipment)
- clinical response and safety of the treatment by radiotherapy [18 Months (cervix and canal anal) or 36 months (prostate)]
Assess the skin and mucosal toxicity (acute, delayed) : CTCAEv3 Assess the prognostic factors of onset of toxicity Assess oncological results
Eligibility Criteria
Criteria
Inclusion Criteria:
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WHO performance index ≤ 2
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Age > 18 years
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histologically proven carcinoma: Anal canal cancer locally advanced (> 4 cm and / or N1 to N3) under irradiation on pelvic and inguinal lymph nodes with concurrent chemotherapy. The boost with brachytherapy are accepted Prostate cancer with pelvic lymph nodes and radiation or hormone therapy Cervical Cancer under a purely medical treatment involving irradiation on pelvic lymph nodes and primary tumor with concurrent chemotherapy without surgery. The Boost by external radiotherapy or brachytherapy are accepted.
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The investigator must ensure that the patient has not expressed its opposition to participate in this study. The signing of a consent form is optional;
Exclusion Criteria:
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History of invasive cancer other than basal cell carcinomas.
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Indication of re-irradiation
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para-aortic radiotherapy associated with pelvic irradiation.
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post-operative radiotherapy.
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geographical distance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Sainte Catherine | Avignon | France | 84000 | |
| 2 | Institut Bergonié | Bordeaux | France | 33000 | |
| 3 | Centre Léon Bérard | Lyon | France | 69373 | |
| 4 | Institut Paoli Calmette | Marseille | France | 13273 | |
| 5 | Assistance publique des Hôpitaux de Marseille | Marseille | France | 13385 | |
| 6 | Hôpital Clinique Claude Bernard | Metz | France | 57 070 | |
| 7 | Groupe Oncorad | Montauban | France | 82000 | |
| 8 | Centre Val d'Aurelle | Montpellier | France | 34298 | |
| 9 | Centre Alexis Vautrin | Nancy | France | 54500 | |
| 10 | Institut Curie | Paris | France | 75013 | |
| 11 | Hôpital Européen Georges Pompidou | Paris | France | 75015 | |
| 12 | Centre René Gauducheau | Saint Herblain | France | ||
| 13 | Centre Paul Strauss | Strasbourg | France | 67065 | |
| 14 | Institut Claudius Regaud | Toulouse | France | 31000 | |
| 15 | Groupe Oncorad | Toulouse | France | 31300 |
Sponsors and Collaborators
- Institut Cancerologie de l'Ouest
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRD 10/12-O