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Completed

NCT Number: NCT01325961

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

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMRT using Rapid Arc - prostate cancer

Radiation

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

IMRT using Rapid Arc - Anal canal cancer

Radiation

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

IMRT using Rapid Arc - Cervix cancer

Radiation

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

IMRT with HT - prostate cancer

Radiation

IMRT using helical tomotherapy (HT) technique with prostate cancer

IMRT with HT - Anal canal cancer

Radiation

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

IMRT with HT - cervix cancer

Radiation

IMRT using helical tomotherapy (HT) technique with cervix cancer

IMRT with VMAT - prostate cancer

Radiation

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

IMRT with VMAT - Anal canal cancer

Radiation

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

IMRT with VMAT - cervix cancer

Radiation

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Others Economic Criteria

    Time frame: 3 Months

    the estimation of the cost differential by individualizing the planning costs and session costs

  2. Clinical Response of the Treatment by Radiotherapy

    Time frame: 12 months

    Assess oncological results : Relapse Free Survival (RFS) at 12 months

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study 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

Acronym: RCMI-PELVIS

Important dates

Study start
2011
Primary completion
2015
Study completion
2020
First posted
Mar 30, 2011
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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