About this trial
The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required.
This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.
Eligibility criteria
Qualifiers
Newly diagnosed biopsy proven FIGO (2018) clinical stage IB3-IVA cervical carcinoma.
Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
Candidate for definitive radiation therapy as determined by treating radiation oncologist.
At least 18 years of age.
Disqualifiers
Any prior pelvic radiotherapy.
Any prior gynecologic or other pelvic malignancy.
Any prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for the trial.
Evidence of metastatic disease outside of the pelvis or para-aortic nodes.
Trial design
Treatments tested in this trial
- Hypofractionated external beam radiation
- Chemotherapy
- Image-guided brachytherapy
Treatment groups
Sponsors and collaborators
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator