MR-guidance in Chemoradiotherapy for Cervical Cancer (AIM-C1)

March 6, 2026 updated by: Juergen Debus

Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial will be conducted as a prospective, one-armed phase II study in 40 patients with cervical carcinoma (FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1), age ≥ 18 years, Karnofsky Performance Score ≥ 70%. CCRT will consist of 50.4Gy external beam radiotherapy (EBRT) with concurrent cisplatin 40mg/m² as standard of care in Germany, followed by 27Gy of BT in 4 fractions of 7Gy.

The primary endpoint of the trial will be the occurrence of overall early bowel and bladder toxicity CTCAE grade 2 or higher assessed within the first 3 months with NCI CTCAE Version 5.0.

Secondary outcomes to be investigated are clinical feasibility of daily CBCT-guided and weekly MR-guided plan adaptation, local tumor control, distant tumor control, progression-free survival, overall survival, quality of life, acquisition and comparison of different MRI sequences, technical analyses of treatment, adaptation frequency and morphological as well as functional tumor characteristics of the MRI.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • University Hospital of Heidelberg, Radiation Oncology
        • Principal Investigator:
          • Juliane Hörner-Rieber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related bladder toxicity
Time Frame: within 3 month after completion of radiation treatment
Occurrence of bladder toxicity grade 2 or higher according to CTCAE V5.0
within 3 month after completion of radiation treatment
Treatment-related bowl toxicity
Time Frame: within 3 month after completion of radiation treatment
Occurrence of bowl toxicity grade 2 or higher according to CTCAE V5.0
within 3 month after completion of radiation treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juergen Debus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADONK-AIM-C1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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