Locally Advanced CancerGynecolunityNCT05942742
Estimation of Tumor Response With Linac MRI-guided Adaptive Radiotherapy for Locally Advanced Cervical Cancer
An observational study of Locally Advanced Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The management of locally advanced cervical cancer (Figo >IB) is based on radiochemotherapy (RCT) followed by brachytherapy. At present there is no personalized treatment, all patients undergoing radiochemotherapy will follow a conventional treatment by external radiotherapy (46 Gy in 23 sessions associated with… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Cancer
- What is being tested?
- MRI Linac
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Nov 2024
- Phase
- Observational
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients eligible to selection criteria will be included for the next 2 years that is to say 55 patients according to the current active line of patient
Who may be able to join
- Women aged ≥ 18 and ≤ 70 years old.
- Histologically confirmed cervical cancer: stage IB2-IVA squamous cell carcinoma or adenocarcinoma (FIGO 2018 criteria), regardless of pelvic lymph node status, no positive lomboaortic lymph nodes. Patients should have no metastatic localization of disease.
- Performance index ≤ 1 (WHO).
- Hematological function: polymorphonuclear neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 8,5 g/dL.
- Liver function: total bilirubin < 20 µmol/L or < 12mg/L
- Renal function: creatinine clearance MDRD (Modification of diet in renal disease) >40 ml/min creatinine
- Serum pregnancy test within 7 days before the start of study treatment if risk of pregnancy mentioned by the patient
- Patient able to sign an informed consent form
Who cannot join
- Previous treatment with radiotherapy, chemotherapy, targeted therapy or immunotherapy treatment for cancer of the cervix or for any other cancer within the previous 5 years.
- Live vaccine, such as yellow fever vaccine.
- History of pelvic irradiation or prior surgical treatment for cancer of the cervix (excluding diagnostic conization).
- Contraindication to MRI imaging (pace maker, metal prosthesis, phobia, etc.)
- Contraindication to the use of cisplatin.
- Inability to perform the follow-up required by the study for geographical, social or psychological reasons.
- History of HIV, HBV or HCV infection with positive serology.
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Pierre-Bénite
Angela BOROS, Dr, +33 4 78 86 42 56, angela.boros@chu-lyon.fr
Julien Berthiller, Mr, +33 4 27 85 63 01, franck.morin@ifct.fr
About this study
The management of locally advanced cervical cancer (Figo >IB) is based on radiochemotherapy (RCT) followed by brachytherapy. At present there is no personalized treatment, all patients undergoing radiochemotherapy will follow a conventional treatment by external radiotherapy (46 Gy in 23 sessions associated with cisplatin (CDDP) weekly) and brachytherapy to achieve a total equivalent biological dose around 80-90 Gy).The efficacy of this treatment has been proven for most patients, almost 80% being in complete response after RCT. Nevertheless, on an individual scale, there remains a significant variation in the tumor response, with patients who respond from the first week of treatment, "early responders" or, on the contrary, others who present significant tumor residues after external beam radiotherapy.Various macroscopic tumor volume (GTV) response patterns have been identified based on magnetic resonance imaging (MRI) at diagnosis and MRI before brachytherapy, implying very different clinical target volumes for brachytherapy technique. The difference in tumor volume response has been identified as having a major impact on treatment response.
This is the first study attempting to evaluate tumor response in real time during radiochemotherapy treatment. Knowing the tumor response during treatment will make it possible to modify the management of locally advanced cervical cancer, several therapeutic options might then be discussed depending on the early response to treatment: dose de-escalation for early responders, reduction of time total treatment, personalization of brachytherapy management (technique and dose).
This observational study will allow rapid identification of responder and non-responder patients and might be used as a basis for personalized treatment strategies
- Conditions
- Locally Advanced Cancer
- Being tested
- MRI Linac
- Keywords
- Cervical cancer, Linac MRI, Radiotherapie
- 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.
MRI LinacDevice
External radiotherapy will be performed at Linac MRI, 25 fractions of radiation will be delivered for each patient.The MR-linac offers the ability to individualise and adapt daily treatment plans based on the position or anatomy of the day, following either a simple 'virtual couch shift' adapt-to-position (ATP) approach, or a more complex full reoptimisation adapt-to-shape (ATS) method based on the recontouring of relevant structures. During each radiation therapy, T2-weighted images and diffusion images will be purchased.Treatment plans can be produced and checked by appropriately trained Radiation Oncologists. Each radiation oncologist will decide based on the anatomy of the day the type of workflow to be used (ADP or ATS) for treatment.Patients will undergo accurate image acquisition, registration and interpretation to make sound clinical judgements and proceed to safe and accurate treatment delivery.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer | Patient treated with Linac MRI for their locally advanced cervical cancer Receives: Device: MRI Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recist criteria
The local response will be defined by the Recist 1.1 criteria on MRI. The response will be binary, i.e. complete response versus the 3 other categories of the Recist 1.1 classification that is to say partial response, stabilization or progression.
Nevertheless will identified 3 favorable situation:
- complete response on MRI and PET scan
- partial response but surgery no performed
- partial response, surgery performed and no disease identified on the anatomopathology results
Measured: 8-10 weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jun 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942742
- Sponsor's protocol ID
- 69HCL23_0133
- Acronym
- Gynecolunity
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Tumor Response With Linac MRI-guided Adaptive Radiotherapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05942742
- Acronym / sponsor ID
- Gynecolunity / 69HCL23_0133
- Conditions
- Locally Advanced Cancer
- Keywords
- Cervical cancer, Linac MRI, Radiotherapie
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- 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 management of locally advanced cervical cancer (Figo >IB) is based on radiochemotherapy (RCT) followed by brachytherapy. At present there is no personalized treatment, all patients undergoing radiochemotherapy will follow a conventional treatment by external radiotherapy (46 Gy in 23 sessions associated with cisplatin (CDDP) weekly) and brachytherapy to achieve a total equivalent biological dose around 80-90 Gy).The efficacy of this treatment has been proven for most patients, almost 80% being in complete response after RCT. Nevertheless, on an individual scale, there remains a significant variation in the tumor response, with patients who respond from the first week of treatment, "early responders" or, on the contrary, others who present significant tumor residues after external beam radiotherapy.Various macroscopic tumor volume (GTV) response patterns have been identified based on magnetic resonance imaging (MRI) at diagnosis and MRI before brachytherapy, implying very different clinical target volumes for brachytherapy technique. The difference in tumor volume response has been identified as having a major impact on treatment response.
This is the first study attempting to evaluate tumor response in real time during radiochemotherapy treatment. Knowing the tumor response during treatment will make it possible to modify the management of locally advanced cervical cancer, several therapeutic options might then be discussed depending on the early response to treatment: dose de-escalation for early responders, reduction of time total treatment, personalization of brachytherapy management (technique and dose).
This observational study will allow rapid identification of responder and non-responder patients and might be used as a basis for personalized treatment strategies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer | – | Device: MRI LinacPatient treated with Linac MRI for their locally advanced cervical cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible to selection criteria will be included for the next 2 years that is to say 55 patients according to the current active line of patient
Key inclusion criteria (8 listed)
- Women aged ≥ 18 and ≤ 70 years old.
- Histologically confirmed cervical cancer: stage IB2-IVA squamous cell carcinoma or adenocarcinoma (FIGO 2018 criteria), regardless of pelvic lymph node status, no positive lomboaortic lymph nodes. Patients should have no metastatic localization of disease.
- Performance index ≤ 1 (WHO).
- Hematological function: polymorphonuclear neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 8,5 g/dL.
- Liver function: total bilirubin < 20 µmol/L or < 12mg/L
Key exclusion criteria (8 listed)
- Previous treatment with radiotherapy, chemotherapy, targeted therapy or immunotherapy treatment for cancer of the cervix or for any other cancer within the previous 5 years.
- Live vaccine, such as yellow fever vaccine.
- History of pelvic irradiation or prior surgical treatment for cancer of the cervix (excluding diagnostic conization).
- Contraindication to MRI imaging (pace maker, metal prosthesis, phobia, etc.)
- Contraindication to the use of cisplatin.
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 |
|---|---|---|
| MRI LinacExternal radiotherapy will be performed at Linac MRI, 25 fractions of radiation will be delivered for each patient.The MR-linac offers the ability to individualise and adapt daily treatment plans based on the position or anatomy of the day, following either a simple 'virtual couch shift' adapt-to-position (ATP) approach, or a more complex full reoptimisation adapt-to-shape (ATS) method based on the recontouring of relevant structures. During each radiation therapy, T2-weighted images and diffusion images will be purchased.Treatment plans can be produced and checked by appropriately trained Radiation Oncologists. Each radiation oncologist will decide based on the anatomy of the day the type of workflow to be used (ADP or ATS) for treatment.Patients will undergo accurate image acquisition, registration and interpretation to make sound clinical judgements and proceed to safe and accurate treatment delivery. | Device | Cervical cancer |
Primary outcome
Recist criteria
Time frame: 8-10 weeks after the end of the treatment
The local response will be defined by the Recist 1.1 criteria on MRI. The response will be binary, i.e. complete response versus the 3 other categories of the Recist 1.1 classification that is to say partial response, stabilization or progression. Nevertheless will identified 3 favorable situation: 1. complete response on MRI and PET scan 2. partial response but surgery no performed 3. partial response, surgery performed and no disease identified on the anatomopathology results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Pierre-Bénite, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Cancer, run by Hospices Civils de Lyon 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recist criteria (time frame: 8-10 weeks after the end of the 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 13 Jul 2023.