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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01325961
Acronym
RCMI-PELVIS
Enrollment
215
Registered
2011-03-30
Start date
2011-03-01
Completion date
2020-02-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Canal Cancers, Cervix Cancer, Prostate Cancer

Keywords

prostate, pelvic node irradiation, cervix, anal canal, IMRT, Helical Tomotherapy, Dynamic arc therapy, RapidArc, VMAT

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.

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.

Interventions

RADIATIONIMRT using Rapid Arc - prostate cancer

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

RADIATIONIMRT using Rapid Arc - Anal canal cancer

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

RADIATIONIMRT using Rapid Arc - Cervix cancer

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

RADIATIONIMRT with HT - prostate cancer

IMRT using helical tomotherapy (HT) technique with prostate cancer

RADIATIONIMRT with HT - Anal canal cancer

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

RADIATIONIMRT with HT - cervix cancer

IMRT using helical tomotherapy (HT) technique with cervix cancer

RADIATIONIMRT with VMAT - prostate cancer

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

RADIATIONIMRT with VMAT - Anal canal cancer

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

RADIATIONIMRT with VMAT - cervix cancer

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

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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;

Exclusion criteria

* 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORStéphane SUPIOT, MD, PhD

Institut de Cancérologie de l'Ouest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026