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

NCT ID: NCT01325961

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Cervical Cancer Anal Canal Cancers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Sainte Catherine

Avignon, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Assistance publique des Hôpitaux de Marseille

Marseille, , France

Site Status

Hôpital Clinique Claude Bernard

Metz, , France

Site Status

Groupe Oncorad

Montauban, , France

Site Status

Centre Val d'Aurelle

Montpellier, , France

Site Status

Centre Alexis Vautrin

Nancy, , France

Site Status

Institut Curie

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Centre René Gauducheau

Saint-Herblain, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Groupe Oncorad

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BRD 10/12-O

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.