Using MRI-guided radiotherapy to assess tumor response in advanced cervical cancer
Estimation of Tumor Response With Linac MRI-guided Adaptive Radiotherapy for Locally Advanced Cervical Cancer
This study is testing if using MRI-guided radiotherapy can help women with advanced cervical cancer see how their tumors respond to treatment and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Pierre-Benite) |
| Trial ID | NCT05942742 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women with locally advanced cervical cancer who will undergo radiochemotherapy followed by brachytherapy. The aim is to evaluate tumor response using MRI-guided adaptive radiotherapy, which may allow for personalized treatment approaches based on individual tumor response patterns. The study will monitor changes in tumor volume and response over the course of treatment, providing insights into the effectiveness of this method compared to conventional treatment. By identifying early responders and those with significant tumor residues, the study seeks to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 70 with histologically confirmed stage IB2-IVA cervical cancer and no prior treatment for cervical cancer.
Not a fit: Patients with previous treatments for cervical cancer or any other cancer within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies for patients with locally advanced cervical cancer, potentially improving their outcomes.
How similar studies have performed: While the use of MRI in radiotherapy is gaining traction, this specific approach to adaptive radiotherapy for cervical cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pierre-Benite
- Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie — Pierre-Benite, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.