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.
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.
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.
Single group
Hypofractionated external beam radiation
RadiationCentral pelvis (19.05 Gy in 15 fractions), nodal basins (40 Gy in 15 fractions), with a simultaneous integrated boost to grossly positive lymph nodes (48 Gy in 15 fractions)
Chemotherapy
DrugConcurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines
Image-guided brachytherapy
RadiationHDR boost 7.3 Gy x 6 fractions
Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant
-Must be at least possibly related to RT.
Local recurrence-free survival (LRFS)
A local recurrence is defined as histologic or radiographic evidence of cancer in the cervix. Local recurrence-free survival is defined as the duration of time from the start of treatment to the time of local recurrence or death, whichever occurs first. The living patients with CR, PR, or SD in the cervix are censored at the corresponding date.
Regional recurrence-free survival (LRFS)
A regional recurrence is defined as histologic or radiographic evidence of cancer in the pelvic or para-aortic nodes. Regional recurrence-free survival is defined as the duration of time from the start of treatment to the time of regional recurrence or death, whichever occurs first. The living patients with CR, PR, or SD in the pelvis or para-aortic lymph nodes are censored at the corresponding date.
Progression-free survival (PFS)
Progression- free survival is defined as the duration of time from the start of treatment to progression or death, whichever occurs first. The living patients without progression are censored at the last follow-up.
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Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
