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Cervical AdenocarcinomaPhase 2TRIDICOLNCT02880007

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

A Phase 2 study testing External Beam Radiation Therapy, PDR Brachytherapy and Cisplatin in people with Cervical Adenocarcinoma and Stage IB Cervical Cancer, run by Institut de Cancérologie de Lorraine at 9 sites in France.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
External Beam Radiation Therapy, PDR Brachytherapy and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
9 sitesFrance
Study dates
6 Jun 2011to 1 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CHU de Besançon

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Centre Léon Bérard

    Lyon, 69373

  • Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre Claudius Regaud

    Toulouse, 31052

  • CHRU Tours - Hôpital Bretonneau

    Tours, 37044

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

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

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.

Read the 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
Being tested
External Beam Radiation Therapy, PDR Brachytherapy, Cisplatin
Keywords
Pulsed dose-rate brachytherapy, 3D dosimetry, Prospective Studies, Radiotherapy Dosage, Uterine Cervical Neoplasms/radiotherapy, Brachytherapy/methods
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • External Beam Radiation TherapyRadiation

    Also called EBRT

    45 Gy pelvis / 25 fr

  • PDR BrachytherapyRadiation

    1 puls/hour ; 12 Gy / day

  • CisplatinDrug

    Also called CDDP

    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

Study groups in NCT02880007
Study groupRoleWhat they receive
ARM AExperimentalDose Optimization in 3D Pulsed Dose Rate Brachytherapy
Receives: Radiation: External Beam Radiation Therapy; Radiation: PDR Brachytherapy; Drug: Cisplatin

What is being measured

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

  1. 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

    Measured: 24 months

Secondary outcomes (3)

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

Timeline

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

  1. First posted26 Aug 2016 (estimated)
  2. Study start6 Jun 2011
  3. Primary completion10 Feb 2014
  4. Study completion1 Jul 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880007
Sponsor's protocol ID
2010-A00235-34
Acronym
TRIDICOL
Status last verified
Aug 2026
First submitted
10 Aug 2016
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Charra-Brunaud C, Salleron J, Menoux I, Peignaux K, Ducassou A, Petit A, Pommier P, Barillot I, Serre AA, Thomas L, Delannes M, Thibouw D, Antoni D, Renard S, Peiffert D. [Dose optimization in 3D pulsed dose rate brachytherapy for patients with locally advanced cervical cancer: A French multicenter phase II trial]. Cancer Radiother. 2022 May;26(3):474-480. doi: 10.1016/j.canrad.2021.06.030. Epub 2021 Jul 21. French.

    PubMed 34301498

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing External Beam Radiation Therapy, PDR Brachytherapy and Cisplatin in people with Cervical Adenocarcinoma and Stage IB Cervical Cancer, run by Institut de Cancérologie de Lorraine at 9 sites in France.

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 11 inclusion and 12 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Increase the local control rate (time frame: 24 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 NCT02880007, which also lists 1 linked publication.

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 1 Sep 2026.

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