Clinical trial NCT01325961: Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Cervical Cancer
Anal Canal Cancers
Keywords: prostate, cervical and anal canal cancers with pelvic lymph node irradiation
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Medico-economic study : medical cost differential between 3 ways of Radiotherapy by IMRT (helical tomotherapy and dynamic arc therapy : RapidArc and VMAT).
timeFrame: 2 months
Secondary outcomes:
measure: Others economic criteria
timeFrame: 2 months
measure: clinical response and safety of the treatment by radiotherapy
timeFrame: 18 Months (cervix and canal anal) or 36 months (prostate)
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Marseille
country: France
facility: Assistance publique des Hôpitaux de Marseille
city: Metz
country: France
facility: Hôpital Clinique Claude Bernard
city: Montauban
country: France
facility: Groupe Oncorad
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Toulouse
country: France
facility: Groupe Oncorad
Study officials:
References: