NCT06142760 MR-guidance in Chemoradiotherapy for Cervical Cancer
| NCT ID | NCT06142760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Juergen Debus |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-11-15 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy (EBRT) and chemotherapy, followed by brachytherapy (BT) is the standard of care for patients with locally advanced cervical carcinoma. In current clinical practice, conventionally, one radiotherapy plan based on the initial planning computed tomography (CT) and magnetic resonance imaging (MRI) scan of the pelvis is applied for the complete 5-6 weeks of EBRT. However, there is a high degree of cervix and uterus motion in the pelvis due to different fillings of the bladder and the bowel. Consequently, large safety margins are required to compensate for organ movement, potentially leading to higher toxicity. Lately, daily high-quality cone-beam CT (CBCT) guided adaptive radiotherapy, aided by artificial intelligence (AI), became clinically available. Due to the improved soft-tissue contrast, the treatment plan can now be online adapted to the current position of the tumor and the adjacent organs-at-risk (OAR), while the patient is lying on the treatment couch. Moreover, the German Research Cancer Center offers the unique possibility of additional weekly magnetic resonance imaging (MRI) in treatment position using a shuttle system. Daily CBCT-adapted EBRT in combination with weekly MRI in treatment position might therefore offer superior sparing of surrounding OAR and consequently reduction of treatment-associated side-effects. However, to the investigators knowledge, no toxicity data for daily CBCT/AI adaptive EBRT of locally advanced cervical cancer with additional MR-guidance exists. The AIM-C1 trial therefore aims to assess the potential of daily CBCT adaptive and AI aided EBRT combined with additional weekly offline MR-guidance in treatment position using a shuttle system.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06142760 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06142760 currently recruiting?
Yes, NCT06142760 is actively recruiting participants. Contact the research team at Juliane.hoerner-rieber@med.uni-heidelbeg.de for enrollment information.
Where is the NCT06142760 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT06142760 clinical trial?
NCT06142760 is sponsored by Juergen Debus. The trial plans to enroll 40 participants.
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