Locally Advanced Cervical Carcinoma
Conditions
Keywords
Cervical cancer, Hypofractionated RT, Brachytherapy, Pembrolizumab
Brief summary
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.
Interventions
RADIATIONHypofractionated external beam radiation
Central 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)
DRUGChemotherapy
Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines
RADIATIONImage-guided brachytherapy
HDR boost 7.3 Gy x 6 fractions
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * ECOG performance status ≤ 2 * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representative may sign and give informed consent on behalf of study participants.
Exclusion criteria
* 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. * Previous hysterectomy or planned hysterectomy as part of initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation. * Major surgery ≤ 3 weeks prior to initiating protocol therapy; if a patient has had major surgery prior to 3 weeks, they must have recovered from any surgical effects. * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant | Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks) | -Must be at least possibly related to RT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence-free survival (LRFS) | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) | 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) | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) | 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) | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) | 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. |
Countries
United States
Contacts
CONTACTStephanie Markovina, M.D.
PRINCIPAL_INVESTIGATORStephanie Markovina, M.D.
Washington University School of Medicine
Outcome results
None listed