MR-guidance in Chemoradiotherapy for Cervical Cancer

NCT06142760 | Recruiting

• 1 other identifier: RADONK-AIM-C1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Treatment-related bladder toxicity

  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

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

  within 3 month after completion of radiation treatment

Interventions

MR-guided radiation RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• years of age
• Capacity of the patient to consent to participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Juergen Debus: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Juliane Hörner-Rieber, MD

CONTACT

+496221 56; Juliane.hoerner-rieber@med.uni-heidelbeg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department head

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)