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)
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).
Arms & interventions
- DeviceVarian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Outcome measures
Primary
Acute Patient Reported Outcome (PRO) GI Toxicity
GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire
Time frame: End of external beam treatment delivery (week 5)
Secondary
Key powered secondary endpoint: Fecal Urgency
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Bowel Toxicity
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Urinary Toxicity
Time frame: End of external beam treatment delivery (week 5)
Patient Reported Quality by EQ-5D-5L
Time frame: 24 months post treatment
Patient Reported Quality by EORTC
Time frame: 24 months post treatment
Disease-free Survival
Time frame: Enrollment through 2 year follow up
Normal Tissue Complication Probability Model
Time frame: Enrollment through 2 year follow up
Workflow Feasibility
Time frame: End of external beam treatment delivery
CTCAE Toxicities
Time frame: Enrollment through 2 year follow up
Eligibility criteria
Study locations (5)
University of Alabama Birmingham
Burmingham, Alabama, 35233
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92037
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Texas Southwestern
Dallas, Texas, 75390