New treatment approach for locally advanced cervical cancer
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
This study is testing a new treatment for locally advanced cervical cancer that combines different types of radiation and chemotherapy to see if it can improve recovery and reduce side effects for patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06529809 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new treatment method for locally advanced cervical cancer that combines upfront brachytherapy with hypofractionated external beam radiation and chemotherapy. The goal is to reduce overall treatment time, which is crucial for improving patient outcomes. The study will assess the impact of this approach on late gastrointestinal and genitourinary toxicity, recurrence-free survival, and the immune response in patients. It targets patients with specific stages of cervical cancer to determine the feasibility and effectiveness of this treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed FIGO stage IB3-IVA cervical carcinoma.
Not a fit: Patients with prior pelvic radiotherapy or those with metastatic disease outside of the pelvis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced side effects for patients with locally advanced cervical cancer.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being explored for the first time.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jessika A Contreras, M.D. — Washington University School of Medicine
- Study coordinator: Jessika A Contreras, M.D.
- Email: jcontreras@wustl.edu
- Phone: 314-747-7236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.