Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06142760

MR-guidance in Chemoradiotherapy for Cervical Cancer

Led by Juergen Debus · Updated on 2026-03-09

40

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MR-guidance in Chemoradiotherapy for Cervical Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma
  • FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1
  • Eligibility for definitive chemoradiotherapy including brachytherapy confirmed by interdisciplinary tumor board
  • Karnofsky performance score 70% or higher
  • Age between 18 and 80 years
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • FIGO stage IIIC2 or IV
  • Paraaortic lymphatic node metastases
  • Small cell neuroendocrine cancer, melanoma, or other rare cervical cancers
  • Previous radiotherapy to the pelvic region
  • Previous total or partial hysterectomy
  • Neoadjuvant chemotherapy
  • Contraindications to contrast-enhanced MRI (e.g., pacemakers, implants, gadolinium allergy)
  • Claustrophobia
  • Pregnant or lactating women
  • Other primary malignancies within 5 years except carcinoma in situ of cervix or basal cell carcinoma of skin
  • Enrollment in another study that could affect outcomes

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

J

Juliane Hörner-Rieber, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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