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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)

Primary Purpose

Prostate Cancer, Cervical Cancer, Anal Canal Cancers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensity-Modulated Radiation Therapy
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring prostate, cervical and anal canal cancers with pelvic lymph node irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Sainte Catherine
  • Institut Bergonié
  • Centre Léon Bérard
  • Institut Paoli Calmette
  • Assistance publique des Hôpitaux de Marseille
  • Hôpital Clinique Claude Bernard
  • Groupe Oncorad
  • Centre Val d'Aurelle
  • Centre Alexis Vautrin
  • Institut Curie
  • Hôpital Européen Georges Pompidou
  • Centre René Gauducheau
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Groupe Oncorad

Outcomes

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).
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
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
Assess the skin and mucosal toxicity (acute, delayed) : CTCAEv3 Assess the prognostic factors of onset of toxicity Assess oncological results

Full Information

First Posted
March 28, 2011
Last Updated
May 20, 2021
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT01325961
Brief Title
Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Cervical Cancer, Anal Canal Cancers
Keywords
prostate, cervical and anal canal cancers with pelvic lymph node irradiation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Assistance publique des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Clinique Claude Bernard
City
Metz
ZIP/Postal Code
57 070
Country
France
Facility Name
Groupe Oncorad
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Groupe Oncorad
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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