NCT01325961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 24, 2021

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

March 28, 2011

Last Update Submit

May 20, 2021

Conditions

Prostate CancerCervical CancerAnal Canal Cancers

Keywords

prostate, cervical and anal canal cancers with pelvic lymph node irradiation

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 months

Secondary Outcomes (2)

  • Others economic criteria

    2 months

  • clinical response and safety of the treatment by radiotherapy

    18 Months (cervix and canal anal) or 36 months (prostate)

Interventions

Intensity-Modulated Radiation TherapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Institut Sainte Catherine

Avignon, 84000, France

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

Assistance publique des Hôpitaux de Marseille

Marseille, 13385, France

Location

Hôpital Clinique Claude Bernard

Metz, 57 070, France

Location

Groupe Oncorad

Montauban, 82000, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Alexis Vautrin

Nancy, 54500, France

Location

Institut Curie

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Centre René Gauducheau

Saint-Herblain, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Regaud

Toulouse, 31000, France

Location

Groupe Oncorad

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Prostatic NeoplasmsUterine Cervical Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2015

Study Completion

February 1, 2020

Last Updated

May 24, 2021

Record last verified: 2016-08

Locations

FR(15)