Using MR-guidance in Chemoradiotherapy for Cervical Cancer
Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1
This study is testing if using real-time imaging during radiation and chemotherapy can help people with advanced cervical cancer get better treatment while reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06142760 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of MR-guided radiation therapy in conjunction with concurrent chemoradiotherapy for patients with locally advanced cervical cancer. It aims to adapt treatment plans in real-time based on daily imaging to improve targeting of the tumor while minimizing damage to surrounding organs. The study will enroll 40 patients and assess early bowel and bladder toxicity as the primary endpoint, along with secondary outcomes such as tumor control and quality of life. The approach leverages advanced imaging techniques to enhance treatment precision and patient safety.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with biopsy-proven cervical cancer at specific FIGO stages and a Karnofsky performance score of 70% or higher.
Not a fit: Patients with advanced stages of cervical cancer (FIGO stage IIIC2 and IV) or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce treatment-related toxicity and improve outcomes for patients with cervical cancer.
How similar studies have performed: While the use of adaptive radiotherapy is gaining traction, this specific application of MR-guidance in cervical cancer treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma * FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1 * indication and eligibility for definitive chemoradiotherapy including brachytherapy discussed in an interdisciplinary tumor board * Karnofsky performance score ≥ 70% * 18-80 years of age * Capacity of the patient to consent to participation in the study Exclusion Criteria: * FIGO stage IIIC2 and IV * Paraaortic lymphatic node metastases * small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix * previous radiotherapy of the pelvic region * previous total or partial hysterectomy * neoadjuvant chemotherapy * contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent) * claustrophobia * pregnant or lactating women * other primary malignancies within 5 years before except carcinoma in situ of the cervix and basal cell carcinoma of the skin * patient is enrolled in another study, that could influence the outcome of the presented study
Where this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Juliane Hörner-Rieber, MD
- Email: Juliane.hoerner-rieber@med.uni-heidelbeg.de
- Phone: +496221 56
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.