Cervical CancerVESICOLNCT02865837
Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer
A study testing brachytherapy in people with Cervical Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- brachytherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Aug 2016
- Phase
- Interventional
- 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
- Age > or = 18 years old
- with a cervical cancer histologically proven (squamous cell carcinoma, adenocarcinoma and neuroendocrine cell carcinoma)
- Utero-vaginal brachytherapy indications::
- Stage 1B1: brachytherapy before surgery
- Stages IB2 to IIIB: after pelvic radiotherapy (45Gy/25 fractions/5 weeks) with or without concomitant chemotherapy
- Ability to provide an informed written consent form
- Patient must be affiliated to a social security system
Who cannot join
- Age < 18 years old
- History of pelvic radiotherapy
- History of pelvic surgery
- Recent joint prothesis (<3 months)
- Pregnant woman or being breastfeeding
- Patients deprived of liberty or under supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer
The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- brachytherapy
- Keywords
- Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer
- 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.
brachytherapyOther
The brachytherapy applicator and a urinary catheter are set up in the operating room under general anesthesia.
Then, an MRI (or a scanner if contra-indication) is performed after a bladder filling with 120cc of normal saline solution and urinary catheter clamping.
Right after, a scanner is performed with urinary catheter declamping and emptied bladder.
Delineation of CTVs and organs at risk (bladder, rectum, sigmoid, small bowel), and dosimetric optimisation are made on study with filled bladder.
Then, organs at risk are delineated on the study with emptied bladder. The prior dosimetry is reset on this study and organs at risk doses are compared.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Not described Receives: Other: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.
Measured: 1 day
Secondary outcomes (5)
Non-inferiority based on the dose received by the rectum
Measured: 1 day
Non-inferiority based on the dose received by the sigmoid
Measured: 1 day
Non-inferiority based on the dose received by the small bowel
Measured: 1 day
FIGO staging system
Measured: 1 day
Body Mass Index
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RENARD OLDRINI SOPHIE, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865837
- Sponsor's protocol ID
- 2015-A00923-46
- Acronym
- VESICOL
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2016
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nesseler JP, Charra-Brunaud C, Salleron J, Py JF, Huertas A, Meknaci E, Courrech F, Peiffert D, Renard-Oldrini S. Effect of bladder distension on doses to organs at risk in Pulsed-Dose-Rate 3D image-guided adaptive brachytherapy for locally advanced cervical cancer. Brachytherapy. 2017 Sep-Oct;16(5):976-980. doi: 10.1016/j.brachy.2017.06.003. Epub 2017 Jul 8.
PubMed 28694116
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer
- ClinicalTrials.gov ID
- NCT02865837
- Acronym / sponsor ID
- VESICOL / 2015-A00923-46
- Conditions
- Cervical Cancer
- Keywords
- Brachytherapy, Organs at Risk, Bladder volume, Cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Other: brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > or = 18 years old
- with a cervical cancer histologically proven (squamous cell carcinoma, adenocarcinoma and neuroendocrine cell carcinoma)
- Utero-vaginal brachytherapy indications::
- Ability to provide an informed written consent form
- Patient must be affiliated to a social security system
Key exclusion criteria (6 listed)
- Age < 18 years old
- History of pelvic radiotherapy
- History of pelvic surgery
- Recent joint prothesis (<3 months)
- Pregnant woman or being breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brachytherapyThe brachytherapy applicator and a urinary catheter are set up in the operating room under general anesthesia. Then, an MRI (or a scanner if contra-indication) is performed after a bladder filling with 120cc of normal saline solution and urinary catheter clamping. Right after, a scanner is performed with urinary catheter declamping and emptied bladder. Delineation of CTVs and organs at risk (bladder, rectum, sigmoid, small bowel), and dosimetric optimisation are made on study with filled bladder. Then, organs at risk are delineated on the study with emptied bladder. The prior dosimetry is reset on this study and organs at risk doses are compared. | Other | ARM 1 |
Primary outcome
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder
Time frame: 1 day
Difference of the maximum dose received by 2 cm3 bladder (D2cc) between the two conditions: full and empty.
5 secondary outcomes
Non-inferiority based on the dose received by the rectum
Time frame: 1 day
Non-inferiority based on the dose received by the sigmoid
Time frame: 1 day
Non-inferiority based on the dose received by the small bowel
Time frame: 1 day
FIGO staging system
Time frame: 1 day
Body Mass Index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 28694116Nesseler JP, Charra-Brunaud C, Salleron J, Py JF, Huertas A, Meknaci E, Courrech F, Peiffert D, Renard-Oldrini S. Effect of bladder distension on doses to organs at risk in Pulsed-Dose-Rate 3D image-guided adaptive brachytherapy for locally advanced cervical cancer. Brachytherapy. 2017 Sep-Oct;16(5):976-980. doi: 10.1016/j.brachy.2017.06.003. Epub 2017 Jul 8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RENARD OLDRINI SOPHIE, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brachytherapy in people with Cervical Cancer, run by Institut de Cancérologie de Lorraine at 1 site 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 7 inclusion and 6 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Demonstrate the non inferiority of 3D image-guided brachytherapy with emptied bladder compared to filled bladder for the dose received by the bladder (time frame: 1 day). 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 NCT02865837, 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 27 Mar 2026.