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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT01325961
First received: March 28, 2011
Last updated: September 2, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Prostate Cancer
Cervical Cancer
Anal Canal Cancers
Radiation: Intensity-Modulated Radiation Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 220
Study Start Date: March 2011
Estimated Study Completion Date: February 2020
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325961

Locations
France
Institut Sainte Catherine
Avignon, France, 84000
Institut Bergonié
Bordeaux, France, 33000
Centre Léon Bérard
Lyon, France, 69373
Institut Paoli Calmette
Marseille, France, 13273
Assistance publique des Hôpitaux de Marseille
Marseille, France, 13385
Hôpital Clinique Claude Bernard
Metz, France, 57 070
Groupe Oncorad
Montauban, France, 82000
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Alexis Vautrin
Nancy, France, 54500
Institut Curie
Paris, France, 75013
Hôpital Européen Georges Pompidou
Paris, France, 75015
Centre René Gauducheau
Saint Herblain, France
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius Regaud
Toulouse, France, 31000
Groupe Oncorad
Toulouse, France, 31300
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
  More Information

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01325961     History of Changes
Other Study ID Numbers: BRD 10/12-O 
Study First Received: March 28, 2011
Last Updated: September 2, 2016
Health Authority: France : French Health Products Safety Agency (AFSSAPS)

Keywords provided by Institut Cancerologie de l'Ouest:
prostate, cervical and anal canal cancers with pelvic lymph node irradiation

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Anus Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 29, 2016