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

Prostate Cancer Clinical Trial

— RCMI PELVIS  

Official title:

Medico-economic Evaluation Comparing Conformal Radiotherapy With Intensity Modulation (IMRT) Performed by, Helical Tomotherapy (Hi Art) and Dynamic Arc Therapy (RapidArc, VMAT) in Cancers With Pelvic Lymph Node Irradiation (Prostate, Cervix, Anal Canal)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325961
• Other study ID #: BRD 10/12-O
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: February 2020

Study information

• Verified date: August 2016
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: February 2020
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Canal Cancers
• Anus Neoplasms
• Cervical Cancer
• Prostate Cancer

Intervention

Radiation:
• Intensity-Modulated Radiation Therapy

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Institut Bergonié	Bordeaux
France	Centre Léon Bérard	Lyon
France	Assistance publique des Hôpitaux de Marseille	Marseille
France	Institut Paoli Calmette	Marseille
France	Hôpital Clinique Claude Bernard	Metz
France	Groupe Oncorad	Montauban
France	Centre Val d'Aurelle	Montpellier
France	Centre Alexis Vautrin	Nancy
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Curie	Paris
France	Centre René Gauducheau	Saint Herblain
France	Centre Paul Strauss	Strasbourg
France	Groupe Oncorad	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medico-economic study : medical cost differential between 3 ways of Radiotherapy by IMRT (helical tomotherapy and dynamic arc therapy : RapidArc and VMAT).	Costs of the devices, maintenance costs ; personnel costs directly related to the medical therapeutic procedure (physicians, medical physicists, dosimetry, technicians).	2 months
Secondary	Others economic criteria	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)	2 months
Secondary	clinical response and safety of the treatment by radiotherapy	Assess the skin and mucosal toxicity (acute, delayed) : CTCAEv3; Assess the prognostic factors of onset of toxicity; Assess oncological results	18 Months (cervix and canal anal) or 36 months (prostate)