Adaptive Radiation Therapy for Cervical Cancer

This study is testing a new way to deliver radiation therapy called Varian Ethos Adaptive Radiation Therapy for women with newly diagnosed, advanced cervical cancer (FIGO 2018 clinical stages IB2-IVA). The goal is to see if this adaptive radiation therapy can reduce stomach and bowel side effects (gastrointestinal toxicity) compared to standard radiation therapy. Researchers will measure these side effects at week 5 of treatment, based on what patients report. You may be able to join if you are a woman, 18 years or older, with specific types of cervical cancer that have not spread to certain lymph nodes. The study is currently recruiting about 125 participants.

Study design
This is a single-arm, multi-center study, meaning all participants will receive the Varian Ethos Adaptive Radiation Therapy. It plans to enroll 125 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring side effects is at the end of external beam treatment delivery (week 5).

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NCT05197881

Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix

Recruiting
NAAges 18+InterventionalTreatment
Varian, a Siemens Healthineers Company
~125 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:Varian Ethos Adaptive Radiation Therapy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute Patient Reported Outcome (PRO) GI Toxicity
Measured over End of external beam treatment delivery (week 5)
Cervical Cancer by FIGO Stage 2018
5 sites across 5 states
Alabama1
Arkansas1
California1
Pennsylvania1
Texas1
  • Jyoti Mayadev, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego
  • Xenia Ray, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

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Eligibility criteria

Inclusion

leukocytes ≥ 2,500/mcL
absolute neutrophil count ≥ 1,500/mcL
platelets ≥ 100,000/mcL
hemoglobin ≥ 8 g/dL (can be transfused with red blood cells pre-study)
total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤ 3 × ULN
alkaline phosphatase ≤ 2.5 × ULN
creatinine \< 1.5 mg/dL to receive weekly cisplatin\*
Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is \>30 ml/min. For the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used:CCr=(0.85 ×(140-age)×IBW)/((Scr×72)) where age is the patient's age in years (from 20 to 80 years), Scr is the serum creatinine in mg/dL, and IBW is the ideal body weight in kg (according to the calculation IBW = 45.5 kg + 2.3 kg for each inch over 5 feet). 9. Age ≥ 18 years (or meets local age of consent). 10. Study participant is already intending to be prescribed a standard of care cisplatin treatment regimen. 11. Ability to understand and the willingness to sign a written informed consent document.
  • Acute Patient Reported Outcome (PRO) GI ToxicityEnd of external beam treatment delivery (week 5)

    GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire