MR-guidance in Chemoradiotherapy for Cervical Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuergen Debus

About this trial

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

Qualifiers

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%

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MR-guided radiation

Treatment groups

No treatment groups listed

Sponsors and collaborators

Juergen Debus

Lead sponsor

University Hospital Heidelberg

Sponsor institution