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Completed

NCT Number: NCT02880007

Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer

This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

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Key information

About this study

  • The causes of treatment failure and death in cervical cancer are still often linked to a local cancer progression
  • The importance of local control for healing, than the cervix situation in the center of pelvis between bladder and rectum which are sensitive organs to irradiation justify the use of utero-vaginal brachytherapy
  • This open label, multicenter, phase II study evaluates the benefit of increasing in dose to the target volume at high risk and the intermediate target volume in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.
  • Local control and tolerance are evaluated

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primitive cervical cancer
  • adenocarcinoma histologically advanced
  • IB2, II and III stage
  • curative treatment
  • indication of utero-vaginal brachytherapy with external radiotherapy
  • non-metastatic tumor and life expectancy > 6 months
  • patient informed and follow possible
  • performance status ≤ 2
  • unplanned surgery
  • age ≥ 18 years old
  • ability to provide written informed consent before the start of any study specific procedures

Exclusion criteria

  • primitive endometrial cancer
  • other diseases
  • carcinoma in situ and stages ≤ B
  • distant metastases
  • history of pelvic irradiation or a first pelvic cancer
  • contraindication to MRI
  • history of subtotal or total hysterectomy
  • pregnant or breast feeding females
  • inability to support low dose rate continuous brachytherapy or pulsed flow
  • person in emergencies
  • person unable to give personally consent
  • patient participating in another clinical research except in case of local recurrence or observational research

Treatment and study plan

external beam radiation therapy

Radiation

45 Gy pelvis / 25 fr

Other names: EBRT

PDR Brachytherapy

Radiation

1 puls/hour ; 12 Gy / day

Cisplatin

Drug

increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy

Other names: CDDP

Primary outcomes

  1. Increase the local control rate

    Time frame: 24 months

    Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms

Secondary outcomes

  1. Maintain the cumulative rate grade III and IV complications below 6.5%

    Time frame: 24 months

  2. Relationship between the doses delivered to the target volume and local control

    Time frame: 24 months

  3. Relationship between the doses delivered to the critical organs and rate of grade III and IV complications

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer

Acronym: TRIDICOL

Important dates

Study start
2011
Primary completion
2014
Study completion
2019
First posted
Aug 26, 2016
Registry last updated
Mar 10, 2020

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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