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

This study is currently recruiting participants.

Verified January 2011 by Centre René Gauducheau

Sponsor:

Information provided by:

Centre René Gauducheau

ClinicalTrials.gov Identifier:

NCT01325961

First received: March 28, 2011

Last updated: March 29, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2011
Last Updated Date	March 29, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	March 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 29, 2011)	Medico-economic study : medical cost differential between 3 ways of Radiotherapy by IMRT (helical tomotherapy and dynamic arc therapy : RapidArc and VMAT). [ Time Frame: 2 months ] [ Designated as safety issue: No ] Costs of the devices, maintenance costs ; personnel costs directly related to the medical therapeutic procedure (physicians, medical physicists, dosimetry, technicians).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01325961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 29, 2011)	Others economic criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ] 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 [ Time Frame: 18 Months (cervix and canal anal) or 36 months (prostate) ] [ Designated as safety issue: Yes ] Assess the skin and mucosal toxicity (acute, delayed) : CTCAEv3 Assess the prognostic factors of onset of toxicity Assess oncological results
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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)
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Prostate Cancer Cervical Cancer Anal Canal Cancers
Intervention ^ICMJE	Radiation: Intensity-Modulated Radiation Therapy
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	120
Completion Date	Not Provided
Estimated Primary Completion Date	March 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01325961
Other Study ID Numbers ^ICMJE	BRD 10/12-O
Has Data Monitoring Committee	No
Responsible Party	Mme Scotet-Cérato,, Centre René Gauducheau
Study Sponsor ^ICMJE	Centre René Gauducheau
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre René Gauducheau
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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