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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
University of Alabama Birmingham
Burmingham, Alabama, United States
RECRUITINGUniversity of Arkansas Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGMoores Cancer Center at UC San Diego Health
La Jolla, California, United States
RECRUITINGFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Texas Southwestern
Dallas, Texas, United States
RECRUITINGAcute 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)
Key powered secondary endpoint: Fecal Urgency
Acute reported fecal urgency (as measured by the inability to defer defecation by 15 minutes)
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Bowel Toxicity
Bowel toxicity as reported with EPIC bowel questionnaire
Time frame: End of external beam treatment delivery (week 5)
Acute PRO Urinary Toxicity
Urinary toxicity as reported with EPIC urinary questionnaire
Time frame: End of external beam treatment delivery (week 5)
Patient Reported Quality by EQ-5D-5L
Quality of life as document with EQ-5D-5L patient reported questionnaire
Time frame: 24 months post treatment
Patient Reported Quality by EORTC
Quality of life as document with EORTC patient reported questionnaire
Time frame: 24 months post treatment
Disease-free Survival
Disease-free survival at 2 years
Time frame: Enrollment through 2 year follow up
Normal Tissue Complication Probability Model
Develop a normal tissue complication probability (NTCP) model of acute GI toxicity based on true integrated daily dose to the bowel
Time frame: Enrollment through 2 year follow up
Workflow Feasibility
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
Time frame: End of external beam treatment delivery
CTCAE Toxicities
Physician reported CTCAE toxicities
Time frame: Enrollment through 2 year follow up
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