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

Primary Purpose

Cervical Adenocarcinoma, Stage IB Cervical Cancer, Stage II Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
External Beam Radiation Therapy
PDR Brachytherapy
Cisplatin
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma focused on measuring Pulsed dose-rate brachytherapy, 3D dosimetry, Prospective Studies, Radiotherapy Dosage, Uterine Cervical Neoplasms/radiotherapy, Brachytherapy/methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon
  • Institut Bergonié
  • Centre Georges-François Leclerc
  • Centre Léon Bérard
  • Centre Val d'Aurelle
  • Centre Paul Strauss
  • Centre Claudius Regaud
  • CHRU Tours - Hôpital Bretonneau
  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARM A

Arm Description

Dose Optimization in 3D Pulsed Dose Rate Brachytherapy

Outcomes

Primary Outcome Measures

Increase the local control rate
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 Outcome Measures

Maintain the cumulative rate grade III and IV complications below 6.5%
Relationship between the doses delivered to the target volume and local control
Relationship between the doses delivered to the critical organs and rate of grade III and IV complications

Full Information

First Posted
August 10, 2016
Last Updated
March 6, 2020
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02880007
Brief Title
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer
Acronym
TRIDICOL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2011 (Actual)
Primary Completion Date
February 10, 2014 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Stage IB Cervical Cancer, Stage II Cervical Cancer, Stage III Cervical Cancer
Keywords
Pulsed dose-rate brachytherapy, 3D dosimetry, Prospective Studies, Radiotherapy Dosage, Uterine Cervical Neoplasms/radiotherapy, Brachytherapy/methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Experimental
Arm Description
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
EBRT
Intervention Description
45 Gy pelvis / 25 fr
Intervention Type
Radiation
Intervention Name(s)
PDR Brachytherapy
Intervention Description
1 puls/hour ; 12 Gy / day
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
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
Primary Outcome Measure Information:
Title
Increase the local control rate
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Maintain the cumulative rate grade III and IV complications below 6.5%
Time Frame
24 months
Title
Relationship between the doses delivered to the target volume and local control
Time Frame
24 months
Title
Relationship between the doses delivered to the critical organs and rate of grade III and IV complications
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEIFFERT Didier
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Centre Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
CHRU Tours - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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