Prostate CancerRCMI-PELVISNCT01325961

Medico-economic Evaluation of IMRT by Hi Art, RapidArc, VMAT Therapy in Prostate, Cervix and Anal Canal Cancers

A study testing IMRT using Rapid Arc - prostate cancer, IMRT using Rapid Arc - Anal canal cancer and IMRT using Rapid Arc - Cervix cancer in people with Prostate Cancer and Cervix Cancer, run by Institut Cancerologie de l'Ouest at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prostate Cancer, Cervix Cancer, Anal Canal Cancers
What is being tested?: IMRT using Rapid Arc - prostate cancer, IMRT using Rapid Arc - Anal canal cancer and IMRT using Rapid Arc - Cervix cancer
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 15 sitesFrance
Study dates: Mar 2011to Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

France15 sites

Institut Sainte Catherine
Avignon, 84000
Institut Bergonié
Bordeaux, 33000
Centre Léon Bérard
Lyon, 69373
Institut Paoli Calmette
Marseille, 13273
Assistance publique des Hôpitaux de Marseille
Marseille, 13385
Hôpital Clinique Claude Bernard
Metz, 57 070
Groupe Oncorad
Montauban, 82000
Centre Val d'Aurelle
Montpellier, 34298
Centre Alexis Vautrin
Nancy, 54500
Hôpital Européen Georges Pompidou
Paris, Paris, 75015
Institut Curie
Paris, 75013
Institut de cancérologie de l'ouest
Saint-Herblain, 44800
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31000
Groupe Oncorad
Toulouse, 31300

Other trials in France

About this study

Official title: Medico-economic Evaluation Comparing 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

Read the detailed description

Treatment by IMRT: Radiotherapy Modalities. All volumes will receive a base dose of 45 Gy in 25 fractions or 46 Gy in 23 fractions, followed by additional irradiation doses that vary depending on the type of tumor. The treatment will be carried out in one or more phases.
Patient follow-up: this will take place at 3 months, 6 months, 12 months, and 18 months after the end of irradiation for cervical and anal canal cancers, and extended to 24, 30, and 36 months, then at 4 and 5 years for prostate cancers, with an evaluation of the treatment's effectiveness and tolerance.
Collection of economic and clinical information: Medical data concerning the patient, their disease, and treatment-related toxicity will be collected during the treatment and afterward. The economic study will include measuring the duration of the different stages of preparation and treatment.

Conditions: Prostate Cancer, Cervix Cancer, Anal Canal Cancers
Being tested: IMRT using Rapid Arc - prostate cancer, IMRT using Rapid Arc - Anal canal cancer, IMRT using Rapid Arc - Cervix cancer, IMRT with HT - prostate cancer, IMRT with HT - Anal canal cancer
Keywords: prostate, pelvic node irradiation, cervix, anal canal, IMRT, Helical Tomotherapy, Dynamic arc therapy, RapidArc, VMAT
Medical subject headings: Prostatic Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMRT using Rapid Arc - prostate cancerRadiation
IMRT using Dynamic arc therapy by Rapid Arc technique for patients with prostate cancer
IMRT using Rapid Arc - Anal canal cancerRadiation
IMRT using Dynamic arc therapy by Rapid Arc technique for patients with Anal canal cancer
IMRT using Rapid Arc - Cervix cancerRadiation
IMRT using Dynamic arc therapy by Rapid Arc technique for patients with cervix cancer
IMRT with HT - prostate cancerRadiation
IMRT using helical tomotherapy (HT) technique with prostate cancer
IMRT with HT - Anal canal cancerRadiation
IMRT using helical tomotherapy (HT) technique with Anal canal cancer
IMRT with HT - cervix cancerRadiation
IMRT using helical tomotherapy (HT) technique with cervix cancer
IMRT with VMAT - prostate cancerRadiation
IMRT using Volumetric Modulated Arc Therapy (VMAT) with prostate cancer
IMRT with VMAT - Anal canal cancerRadiation
IMRT using Volumetric Modulated Arc Therapy (VMAT) with Anal canal cancer
IMRT with VMAT - cervix cancerRadiation
IMRT using Volumetric Modulated Arc Therapy (VMAT) with cervix cancer

Study groups in NCT01325961
Study group	Role	What they receive
Prostate	Other	Patients with prostate cancer Receives: Radiation: IMRT using Rapid Arc - prostate cancer; Radiation: IMRT with HT - prostate cancer; Radiation: IMRT with VMAT - prostate cancer
Anal canal	Other	Patients with anal canal Receives: Radiation: IMRT using Rapid Arc - Anal canal cancer; Radiation: IMRT with HT - Anal canal cancer; Radiation: IMRT with VMAT - Anal canal cancer
Cervix cancer	Other	Patients with Cervix cancer Receives: Radiation: IMRT using Rapid Arc - Cervix cancer; Radiation: IMRT with HT - cervix cancer; Radiation: IMRT with VMAT - cervix cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

Medico-economic Study : Medical Cost Differential Between 3 Ways of Radiotherapy by IMRT Using Helical Tomotherapy (HT), Dynamic Arc Therapy (Rapid ARC) or Volumetric Modulated Arc Therapy (VMAT)
Total: Costs of the devices, maintenance costs ; personnel costs directly related to the medical therapeutic procedure (physicians, medical physicists, dosimetry technicians), for the 3 ways of radiotherapy using: Rapid Arc, HT and VMAT
Measured: 2 months

Secondary outcomes (2)

Others Economic Criteria
the estimation of the cost differential by individualizing the planning costs and session costs
Measured: 3 Months
Clinical Response of the Treatment by Radiotherapy
Assess oncological results : Relapse Free Survival (RFS) at 12 months
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Feb 2020

First posted30 Mar 2011 (estimated)
Study startMar 2011
Primary completionMay 2015
Study completionFeb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01325961
Sponsor's protocol ID: BRD 10/12-O
Acronym: RCMI-PELVIS
Status last verified: Aug 2016
First submitted: 28 Mar 2011
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medico-economic Evaluation Comparing 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
ClinicalTrials.gov ID: NCT01325961
Acronym / sponsor ID: RCMI-PELVIS / BRD 10/12-O
Conditions: Prostate Cancer, Cervix Cancer, Anal Canal Cancers
Keywords: prostate, pelvic node irradiation, cervix, anal canal, IMRT, Helical Tomotherapy, Dynamic arc therapy, RapidArc
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: Institut Cancerologie de l'OuestUniversity, hospital or other
Study start: Mar 2011 (actual)
Primary completion: May 2015 (actual)
Study completion: Feb 2020 (actual)
First posted: 30 Mar 2011 (estimated)
Results: Posted 2 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Treatment by IMRT: Radiotherapy Modalities. All volumes will receive a base dose of 45 Gy in 25 fractions or 46 Gy in 23 fractions, followed by additional irradiation doses that vary depending on the type of tumor. The treatment will be carried out in one or more phases.
Patient follow-up: this will take place at 3 months, 6 months, 12 months, and 18 months after the end of irradiation for cervical and anal canal cancers, and extended to 24, 30, and 36 months, then at 4 and 5 years for prostate cancers, with an evaluation of the treatment's effectiveness and tolerance.
Collection of economic and clinical information: Medical data concerning the patient, their disease, and treatment-related toxicity will be collected during the treatment and afterward. The economic study will include measuring the duration of the different stages of preparation and treatment.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prostate	Other	Radiation: IMRT using Rapid Arc - prostate cancer, Radiation: IMRT with HT - prostate cancer, Radiation: IMRT with VMAT - prostate cancerPatients with prostate cancer
Anal canal	Other	Radiation: IMRT using Rapid Arc - Anal canal cancer, Radiation: IMRT with HT - Anal canal cancer, Radiation: IMRT with VMAT - Anal canal cancerPatients with anal canal
Cervix cancer	Other	Radiation: IMRT using Rapid Arc - Cervix cancer, Radiation: IMRT with HT - cervix cancer, Radiation: IMRT with VMAT - cervix cancerPatients with Cervix cancer

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMRT using Rapid Arc - prostate cancerIMRT using Dynamic arc therapy by Rapid Arc technique for patients with prostate cancer	Radiation	Prostate
IMRT using Rapid Arc - Anal canal cancerIMRT using Dynamic arc therapy by Rapid Arc technique for patients with Anal canal cancer	Radiation	Anal canal
IMRT using Rapid Arc - Cervix cancerIMRT using Dynamic arc therapy by Rapid Arc technique for patients with cervix cancer	Radiation	Cervix cancer
IMRT with HT - prostate cancerIMRT using helical tomotherapy (HT) technique with prostate cancer	Radiation	Prostate
IMRT with HT - Anal canal cancerIMRT using helical tomotherapy (HT) technique with Anal canal cancer	Radiation	Anal canal
IMRT with HT - cervix cancerIMRT using helical tomotherapy (HT) technique with cervix cancer	Radiation	Cervix cancer
IMRT with VMAT - prostate cancerIMRT using Volumetric Modulated Arc Therapy (VMAT) with prostate cancer	Radiation	Prostate
IMRT with VMAT - Anal canal cancerIMRT using Volumetric Modulated Arc Therapy (VMAT) with Anal canal cancer	Radiation	Anal canal
IMRT with VMAT - cervix cancerIMRT using Volumetric Modulated Arc Therapy (VMAT) with cervix cancer	Radiation	Cervix cancer

Primary outcome

Medico-economic Study : Medical Cost Differential Between 3 Ways of Radiotherapy by IMRT Using Helical Tomotherapy (HT), Dynamic Arc Therapy (Rapid ARC) or Volumetric Modulated Arc Therapy (VMAT)
Time frame: 2 months
Total: Costs of the devices, maintenance costs ; personnel costs directly related to the medical therapeutic procedure (physicians, medical physicists, dosimetry technicians), for the 3 ways of radiotherapy using: Rapid Arc, HT and VMAT

2 secondary outcomes

Others Economic Criteria
Time frame: 3 Months
Clinical Response of the Treatment by Radiotherapy
Time frame: 12 months

Results and safety

Results posted to the registry on 2 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prostate-Rapid Arc	89	89
Prostate-HT	49	49
Prostate-VMAT	17	17
Anal Canal-Rapid Arc	7	7
Anal Canal-HT	13	13
Anal Canal-VMAT	10	10
Cervix-Rapid Arc	10	10
Cervix-HT	17	17
Cervix-VMAT	3	3

Primary outcome: Medico-economic Study : Medical Cost Differential Between 3 Ways of Radiotherapy by IMRT Using Helical Tomotherapy (HT), Dynamic Arc Therapy (Rapid ARC) or Volumetric Modulated Arc Therapy (VMAT)

Time frame: 2 months. Mean (Standard Deviation). Unit: EUROS

Measure	Prostate-Rapid Arc n = 89	Prostate-HT n = 49	Prostate-VMAT n = 17	Anal Canal-Rapid Arc n = 7	Anal Canal-HT n = 13	Anal Canal-VMAT n = 10	Cervix Cancer-Rapid Arc n = 10	Cervix Cancer-HT n = 17	Cervix Cancer-VMAT n = 3
Value	2400.6 (651.1)	2793.1 (893.6)	2615.7 (409.6)	2383.7 (222.6)	7014.5 (2961.5)	3098.5 (312.4)	1424.1 (597.4)	5177.4 (2586.4)	2477.1 (1085.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events has been collected during 60 months after treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prostate-Rapid Arc	1 of 89 (1.1%)	80 of 89 (89.9%)	9 of 89
Prostate-HT	3 of 49 (6.1%)	48 of 49 (98%)	4 of 49
Prostate-VMAT	0 of 17 (0%)	17 of 17 (100%)	3 of 17
Anal Canal-Rapid Arc	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Anal Canal-HT	3 of 13 (23.1%)	11 of 13 (84.6%)	1 of 13
Anal Canal-VMAT	2 of 10 (20%)	10 of 10 (100%)	1 of 10
Cervix-Rapid Arc	1 of 10 (10%)	10 of 10 (100%)	2 of 10
Cervix-HT	0 of 17 (0%)	14 of 17 (82.4%)	2 of 17
Cervix-VMAT	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stéphane SUPIOT, MD, PhD principal investigator

Institut de Cancérologie de l'Ouest

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medico-economic Study : Medical Cost Differential Between 3 Ways of Radiotherapy by IMRT Using Helical Tomotherapy (HT), Dynamic Arc Therapy (Rapid ARC) or Volumetric Modulated Arc Therapy (VMAT) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01325961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.