Trial Title:
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
NCT ID:
NCT06529809
Condition:
Locally Advanced Cervical Carcinoma
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical cancer
Hypofractionated RT
Brachytherapy
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated external beam radiation
Description:
Central pelvis (20 Gy in 10 fractions), nodal basins (40 Gy in 15 fractions), with a
simultaneous integrated boost to grossly positive lymph nodes (48 Gy in 15 fractions)
Arm group label:
Accelerated Brachytherapy Forward Chemo Radiation Therapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Concurrent chemotherapy are not dictated by the protocol and will follow standard of care
guidelines
Arm group label:
Accelerated Brachytherapy Forward Chemo Radiation Therapy
Intervention type:
Radiation
Intervention name:
Image-guided brachytherapy
Description:
HDR boost 7.3 Gy x 6 fractions
Arm group label:
Accelerated Brachytherapy Forward Chemo Radiation Therapy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessika A Contreras, M.D.
Phone:
314-747-7236
Email:
jcontreras@wustl.edu
Investigator:
Last name:
Jessika A Contreras, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Stephanie Markovina, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Lakomy, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Julie K Schwarz, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yifei Xu, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Dineo Khabele, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Matthew A Powell, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Premal H Thaker, M.D., M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Carolyn McCourt, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Andrea Hagemann, M.D., MSCI
Email:
Sub-Investigator
Investigator:
Last name:
L. Stewart Massad, Jr., M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Brooke E Sanders, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lindsay Kuroki, M.D., MSCI
Email:
Sub-Investigator
Investigator:
Last name:
Eric Laugeman, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Esther Lu, Ph.D.
Email:
Sub-Investigator
Start date:
October 1, 2024
Completion date:
December 31, 2031
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06529809
http://www.siteman.wustl.edu
