Uterine Cervical CancerARCOLNCT02937948
Adaptative Radiotherapy for Locally Advanced Cervical Cancer
A study testing Adaptative treatment plan and External radiotherapy in people with Uterine Cervical Cancer, run by Center Eugene Marquis at 12 sites in France.
Trial summary
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Cancer
- What is being tested?
- Adaptative treatment plan and External radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 12 sitesFrance
- Study dates
- 5 Apr 2017to 11 Apr 2022
- 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
- Cervix carcinoma proved by histology
- According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
- Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
- Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
- Older than 18 years
- Good general status, World Health Organization less or equal to 1
- Signed informed consent
Who cannot join
- History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
- History of pelvic irradiation
- Simultaneous participation to another research that could interfere with the study results
- Pregnant or breastfeeding patient
- Patient under tutor or guardian
- Patient not able to respect medical follow-up for geographical, social or psychological reasons
- Not affiliated to a system of French social security
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut de Cancérologie de l'Ouest
Angers, 49933
Centre François Baclesse
Caen, 14000
CLCC Georges François Leclerc
Dijon, 21034
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
Centre rené Gauducheau
Nantes, 44805
CHU Poitiers
Poitiers, 86021
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
CHU de Tours
Tours, 37044
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
Gustave Roussy
Villejuif, 94805
About this study
Official title: Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.
- Conditions
- Uterine Cervical Cancer
- Being tested
- Adaptative treatment plan, External radiotherapy
- Keywords
- Locally advanced
- 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.
Adaptative treatment planOther
Each patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an "intermediate" one, one to a full bladder.
External radiotherapyRadiation
At the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen.
| Study group | Role | What they receive |
|---|---|---|
| Adaptative Treatment plans | Experimental | A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day. Receives: Other: Adaptative treatment plan; Radiation: External radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
Measured: 3 months after end of radio-chemotherapy treatment
Secondary outcomes (1)
Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03
Measured: 3 months after end of radio-chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start5 Apr 2017
- Primary completion27 May 2020
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937948
- Sponsor's protocol ID
- 2015-02-45-01
- Acronym
- ARCOL
- Status last verified
- Sep 2022
- First submitted
- 13 Oct 2016
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not authorized in France
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT02937948
- Acronym / sponsor ID
- ARCOL / 2015-02-45-01
- Conditions
- Uterine Cervical Cancer
- Keywords
- Locally advanced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 19 Oct 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.
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptative Treatment plans | Experimental | Other: Adaptative treatment plan, Radiation: External radiotherapyA Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day. |
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)
- Cervix carcinoma proved by histology
- According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
- Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
- Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
- Older than 18 years
Key exclusion criteria (7 listed)
- History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
- History of pelvic irradiation
- Simultaneous participation to another research that could interfere with the study results
- Pregnant or breastfeeding patient
- Patient under tutor or guardian
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 |
|---|---|---|
| Adaptative treatment planEach patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an "intermediate" one, one to a full bladder. | Other | Adaptative Treatment plans |
| External radiotherapyAt the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen. | Radiation | Adaptative Treatment plans |
Primary outcome
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
Time frame: 3 months after end of radio-chemotherapy treatment
1 secondary outcome
Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03
Time frame: 3 months after end of radio-chemotherapy treatment
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 2 Sep 2022.
- Individual participant dataSharing planned: No. Not authorized in France
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptative treatment plan and External radiotherapy in people with Uterine Cervical Cancer, run by Center Eugene Marquis at 12 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 7 inclusion and 7 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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?
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03 (time frame: 3 months after end of radio-chemotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.