Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers

Not Applicable

Completed

• Conditions: Cervical Cancer; Prostate Cancer; Anal Canal Cancers

• Registration Number: NCT01325961
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2015-05
• Status Verified: 2016-08
• Study Completion: 2020-02
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• WHO performance index ≤ 2
• Age > 18 years
• 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.
• 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

• History of invasive cancer other than basal cell carcinomas.
• Indication of re-irradiation
• para-aortic radiotherapy associated with pelvic irradiation.
• post-operative radiotherapy.
• geographical distance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (14)

Institut Sainte Catherine; 🇫🇷 Avignon, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Assistance publique des Hôpitaux de Marseille; 🇫🇷 Marseille, France

Hôpital Clinique Claude Bernard; 🇫🇷 Metz, France

Groupe Oncorad; 🇫🇷 Toulouse, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Alexis Vautrin; 🇫🇷 Nancy, France

Institut Curie; 🇫🇷 Paris, France

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