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Cervical CancerAIM-C1NCT06142760

MR-guidance in Chemoradiotherapy for Cervical Cancer

A study testing MR-guided radiation in people with Cervical Cancer, run by Juergen Debus at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Cancer
What is being tested?
MR-guided radiation
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteGermany
Study dates
15 Nov 2023to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juliane Hörner-Rieber, MD contact

+496221 56 ext. 8201

Juliane.hoerner-rieber@med.uni-heidelbeg.de

Germany1 site, 1 recruiting

  • University Hospital of Heidelberg, Radiation Oncology

    Heidelberg, 69120

    Juliane Hörner-Rieber, MD

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Cervical Cancer
Being tested
MR-guided radiation
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR-guided radiationRadiation

    Dayly artifical intelligence-based treatment adaptation under weekly offline MR-guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-related bladder toxicity

    Occurrence of bladder toxicity grade 2 or higher according to CTCAE V5.0

    Measured: within 3 month after completion of radiation treatment

  2. Treatment-related bowl toxicity

    Occurrence of bowl toxicity grade 2 or higher according to CTCAE V5.0

    Measured: within 3 month after completion of radiation treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start15 Nov 2023
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06142760
Sponsor's protocol ID
RADONK-AIM-C1
Acronym
AIM-C1
Status last verified
Mar 2026
First submitted
15 Nov 2023
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MR-guided radiation in people with Cervical Cancer, run by Juergen Debus at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juliane Hörner-Rieber, MD (+496221 56 ext. 8201, Juliane.hoerner-rieber@med.uni-heidelbeg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related bladder toxicity (time frame: within 3 month after completion of radiation treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06142760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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