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
215

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
6.4 years until next milestone

Results Posted

Study results publicly available

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

March 28, 2011

Results QC Date

December 10, 2025

Last Update Submit

June 29, 2026

Conditions

Keywords

prostatepelvic node irradiationcervixanal canalIMRTHelical TomotherapyDynamic arc therapyRapidArcVMAT

Study Arms (3)

Prostate

OTHER

Patients with prostate cancer

Radiation: IMRT using Rapid Arc - prostate cancerRadiation: IMRT with HT - prostate cancerRadiation: IMRT with VMAT - prostate cancer

Anal canal

OTHER

Patients with anal canal

Radiation: IMRT using Rapid Arc - Anal canal cancerRadiation: IMRT with HT - Anal canal cancerRadiation: IMRT with VMAT - Anal canal cancer

Cervix cancer

OTHER

Patients with Cervix cancer

Radiation: IMRT using Rapid Arc - Cervix cancerRadiation: IMRT with HT - cervix cancerRadiation: IMRT with VMAT - cervix cancer

Interventions

IMRT using helical tomotherapy (HT) technique with prostate cancer

Prostate

IMRT using Volumetric Modulated Arc Therapy (VMAT) with cervix cancer

Cervix cancer

IMRT using Dynamic arc therapy by Rapid Arc technique for patients with prostate cancer

Prostate

IMRT using helical tomotherapy (HT) technique with Anal canal cancer

Anal canal

IMRT using helical tomotherapy (HT) technique with cervix cancer

Cervix cancer

IMRT using Volumetric Modulated Arc Therapy (VMAT) with Anal canal cancer

Anal canal

IMRT using Dynamic arc therapy by Rapid Arc technique for patients with Anal canal cancer

Anal canal

IMRT using Dynamic arc therapy by Rapid Arc technique for patients with cervix cancer

Cervix cancer

IMRT using Volumetric Modulated Arc Therapy (VMAT) with prostate cancer

Prostate

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 confirmed carcinoma
  • Locally advanced anal canal cancer (\> 4 cm and/or N1 to N3), requiring irradiation of inguinal and pelvic lymph nodes with concomitant chemotherapy
  • Prostate cancer requiring pelvic lymph node irradiation and hormone therapy
  • Cervical cancer requiring irradiation of the pelvic lymph nodes, the primary tumor, and parametria with concomitant chemotherapy. Surgical resection may be performed after chemoradiotherapy depending on each center's practices. Boosts via external beam 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 (except basal cell carcinoma)
  • Indication for re-irradiation
  • Lombo-aortic lymph node irradiation
  • Postoperative radiotherapy
  • Geographic distance likely to interfere with patient follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hôpital Européen Georges Pompidou

Paris, Paris, 75015, France

Location

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

Institut de cancérologie de l'ouest

Saint-Herblain, 44800, 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 Officials

  • Stéphane SUPIOT, MD, PhD

    Institut de Cancérologie de l'Ouest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
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

July 2, 2026

Results First Posted

July 2, 2026

Record last verified: 2016-08

Locations