Daily AI-Based Treatment Adaptation under Weekly Offline MR Guidance in Chemoradiotherapy for Cervical Cancer 1: The AIM-C1 Trial

Author:

Weykamp Fabian1234ORCID,Meixner Eva123ORCID,Arians Nathalie123ORCID,Hoegen-Saßmannshausen Philipp1234,Kim Ji-Young123ORCID,Tawk Bouchra12345,Knoll Maximilian12345,Huber Peter6,König Laila123,Sander Anja7,Mokry Theresa89,Meinzer Clara9,Schlemmer Heinz-Peter9,Jäkel Oliver10,Debus Jürgen12341112,Hörner-Rieber Juliane1234

Affiliation:

1. Department of Radiation Oncology, Heidelberg University Hospital, 69120 Heidelberg, Germany

2. Heidelberg Institute of Radiation Oncology (HIRO), 69120 Heidelberg, Germany

3. National Center for Tumor Diseases (NCT), 69120 Heidelberg, Germany

4. Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany

5. Division of Molecular and Translational Radiation Oncology, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany

6. Clinical Cooperation Unit Molecular Radiation Oncology, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany

7. Institute of Medical Biometry, University of Heidelberg, 69120 Heidelberg, Germany

8. Department of Radiology, Heidelberg University Hospital, 69120 Heidelberg, Germany

9. Department of Radiology, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany

10. Division of Medical Physics in Radiation Oncology, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany

11. Heidelberg Ion-Beam Therapy Center (HIT), Department of Radiation Oncology, Heidelberg University Hospital, 69120 Heidelberg, Germany

12. German Cancer Consortium (DKTK), Partner Site, 69120 Heidelberg, Germany

Abstract

(1) Background: External beam radiotherapy (EBRT) and concurrent chemotherapy, followed by brachytherapy (BT), offer a standard of care for patients with locally advanced cervical carcinoma. Conventionally, large safety margins are required to compensate for organ movement, potentially increasing toxicity. Lately, daily high-quality cone beam CT (CBCT)-guided adaptive radiotherapy, aided by artificial intelligence (AI), became clinically available. Thus, online treatment plans can be adapted to the current position of the tumor and the adjacent organs at risk (OAR), while the patient is lying on the treatment couch. We sought to evaluate the potential of this new technology, including a weekly shuttle-based 3T-MRI scan in various treatment positions for tumor evaluation and for decreasing treatment-related side effects. (2) Methods: This is a prospective one-armed phase-II trial consisting of 40 patients with cervical carcinoma (FIGO IB-IIIC1) with an age ≥ 18 years and a Karnofsky performance score ≥ 70%. EBRT (45–50.4 Gy in 25–28 fractions with 55.0–58.8 Gy simultaneous integrated boosts to lymph node metastases) will be accompanied by weekly shuttle-based MRIs. Concurrent platinum-based chemotherapy will be given, followed by 28 Gy of BT (four fractions). The primary endpoint will be the occurrence of overall early bowel and bladder toxicity CTCAE grade 2 or higher (CTCAE v5.0). Secondary outcomes include clinical feasibility, quality of life, and imaging-based response assessment.

Funder

VARIAN

Dieter Morszeck Foundation

Publisher

MDPI AG

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