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

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ClinicalTrials.gov Identifier: NCT06142760
Recruitment Status : Recruiting
First Posted : November 21, 2023
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: MR-guided radiation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Intervention Details:
  • Radiation: MR-guided radiation
    Dayly artifical intelligence-based treatment adaptation under weekly offline MR-guidance

Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06142760


Contacts
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Contact: Juliane Hörner-Rieber, MD +496221 56 ext 8201 Juliane.hoerner-rieber@med.uni-heidelbeg.de

Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Juliane Hörner-Rieber, MD         
Sponsors and Collaborators
Juergen Debus
More Information
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Responsible Party: Juergen Debus, Department head, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT06142760    
Other Study ID Numbers: RADONK-AIM-C1
First Posted: November 21, 2023    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
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