Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated external beam radiation, Chemotherapy, Image-guided brachytherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Cervical Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Radiation Hypofractionated 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) - Drug Chemotherapy
Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines - Radiation Image-guided brachytherapy
HDR boost 7.3 Gy x 6 fractions
Primary outcome measures
- Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant [Time frame: Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks)]
Secondary outcome measures (3)
- Local recurrence-free survival (LRFS) [Time frame: Up to 2 year follow-up (estimated to be 2 years and 6 weeks)]
- Regional recurrence-free survival (LRFS) [Time frame: Up to 2 year follow-up (estimated to be 2 years and 6 weeks)]
- Progression-free survival (PFS) [Time frame: Up to 2 year follow-up (estimated to be 2 years and 6 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT06529809 · 202407064 · R37CA287204