Daily Adaptive External Beam Radiation Therapy in the Treatment of Carcinoma of the Cervix: A Prospective Trial of an Individualized Approach for Intestinal Toxicity Reduction (ARTIA-Cervix)
Varian, a Siemens Healthineers Company
Summary
This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT). The timepoint for this assessment will be at week 5 of external beam radiotherapy (EBRT) and will use the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2018 clinical stages IB2-IVA, without involved paraaortic lymph nodes. 2. For patients with involved pelvic lymph nodes, the upper border of the CTV nodal volume may not extend above the confluence of the common iliac arteries with the aorta (i.e., aortic bifurcation). 3. Patients must NOT have had a hysterectomy. 4. Pelvic nodal status is to be confirmed by one or more of the following studies/procedures…
Interventions
- DeviceVarian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Locations (5)
- University of Alabama BirminghamBurmingham, Alabama
- University of Arkansas Medical SciencesLittle Rock, Arkansas
- Moores Cancer Center at UC San Diego HealthLa Jolla, California
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- University of Texas SouthwesternDallas, Texas