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).
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.
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).
Patients must NOT have had a hysterectomy.
Pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MR Scan, fine needle biopsy, extra peritoneal biopsy or laparoscopic biopsy, per institutional standard of care.
Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
Patients with PALN nodal metastasis.
Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy.
Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Single group
Varian Ethos Adaptive Radiation Therapy
DeviceDaily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Acute Patient Reported Outcome (PRO) GI Toxicity
GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire
Key powered secondary endpoint: Fecal Urgency
Acute reported fecal urgency (as measured by the inability to defer defecation by 15 minutes)
Acute PRO Bowel Toxicity
Bowel toxicity as reported with EPIC bowel questionnaire
Acute PRO Urinary Toxicity
Urinary toxicity as reported with EPIC urinary questionnaire
Patient Reported Quality by EQ-5D-5L
Quality of life as document with EQ-5D-5L patient reported questionnaire
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