Estimation of Tumor Response With Linac MRI-guided Adaptive Radiotherapy for Locally Advanced Cervical Cancer (Gynecolunity)

July 12, 2023 updated by: Hospices Civils de Lyon

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Benite, France
        • Recruiting
        • Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical cancer
Patient treated with Linac MRI for their locally advanced cervical cancer
Device: MRI Linac
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-10 weeks after the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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