ARTIA-Cervix: a prospective trial of adaptive radiation therapy for cervical cancer.

BACKGROUND

Conventional radiotherapy for locally advanced cervical cancer uses large treatment margins due to tumor and normal tissue variations over the treatment course. Adaptive radiotherapy modifies the radiation plan at each treatment, allowing reduced treatment margins and the potential for lower gastrointestinal toxicity.

PRIMARY

OBJECTIVE

ARTIA-Cervix investigates the rate of acute grade ≥3 patient-reported gastrointestinal toxicity in patients with locally advanced cervical cancer treated with adaptive radiotherapy.

STUDY HYPOTHESIS: Adaptive radiotherapy reduces acute grade ≥3 patient-reported gastrointestinal toxicity compared with historical rates after non-adaptive external beam radiotherapy.

TRIAL

DESIGN

ARTIA-Cervix is a single-arm, prospective, multi-center trial. All patients receive a standard course of 45 Gy pelvic external beam radiotherapy in 25 fractions over 5 weeks. External beam radiotherapy treatments are adapted to daily patient anatomy. If lymph nodes are involved, the radiation dose to the involved lymph nodes is 55 Gy or 57.5 Gy delivered simultaneously with the pelvic radiation. Patients also receive concurrent weekly cisplatin chemotherapy (40 mg/m2). Pelvic adaptive radiotherapy is followed by standard brachytherapy with optional parametrial boost.

MAJOR INCLUSION/EXCLUSION CRITERIA: ARTIA-Cervix enrolls adults with newly diagnosed, biopsy-proven, locally advanced cervical cancer (stages IB2 to IVA International Federation of Gynecology and Obstetrics 2018 criteria), node-negative and pelvic node-positive. Participants must be planned to receive concurrent radiation and chemotherapy and have normal organ and bone marrow function. The superior extent of pelvic nodal involvement may not extend above the confluence of the common iliac arteries with the aorta.

PRIMARY ENDPOINT: At week 5 of adaptive radiotherapy, gastrointestinal toxicity is evaluated as grade ≥3 on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.

SAMPLE SIZE: The target enrollment is 130 participants.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

RESULTS

Completion of ARTIA-Cervix accrual and presentation of results are targeted for December 2027 and Spring 2028, respectively.

TRIAL REGISTRATION: NCT05197781.