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. (see Contacts and Locations)
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

March 28, 2011
March 29, 2011
March 2011
March 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01325961 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers
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)

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Prostate Cancer
  • Cervical Cancer
  • Anal Canal Cancers
Radiation: Intensity-Modulated Radiation Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
France
 
NCT01325961
BRD 10/12-O
No
Mme Scotet-Cérato,, Centre René Gauducheau
Centre René Gauducheau
Not Provided
Not Provided
Centre René Gauducheau
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP