Background Cervical cancer (CaCu) is the fourth cause of death in women. In patients with locally advanced disease, the treatment of choice is CT/RT, followed by additional boosting with brachytherapy (BT). There is an international decrease in the use of this technique due to financial restrictions. Given the difficulties in using brachytherapy as a boost, several series have described promising results in local control using boost with highly conformal techniques such as stereotactic body radiotherapy (SBRT). On the other hand, prospective studies are scarce and with controversial results. No study has been published that directly compares three-dimensional intracavitary SBRT and BT. In this clinical trial, the researchers aim to demonstrate that boosting with SBRT is not inferior to intracavitary brachytherapy in patients with CC.
Methodology
Primary Objective:
To evaluate the safety and efficacy of concomitant CT/RT followed by Ablative Body Stereotactic Radiotherapy (SBRT) vs Brachytherapy in patients with Cervical Cancer in clinical stage IB3-IIIC1 at INCan.
Secondary Objectives:
The purpose of this study is to evaluate quality of life, local efficacy (local control and time to local recurrence), overall survival, disease-free survival, and time to distant recurrence.
Study Design:
SABRVICAL is a meticulously designed randomized two-arm open-label phase II study to compare QT/RT + SBRT vs QT/RT + Brachytherapy. It will include patients with IB3-IIIC1 CaCu \>18 years of age with adequate renal function. They will be randomized 1:1 to the experimental arm or the standard arm.
Expected Results and Outlook With this study, we aim to assess that the safety and efficacy of concomitant QT/RT with cisplatin followed by SBRT is not inferior to boost with brachytherapy in patients with CaCu IB3-IIIC1. The potential impact of this study is significant, as it could provide new treatment options for hospitals that do not have brachytherapy or have a prolonged waiting list for this procedure.
People with cervical cancer >18 years of age.
Signed informed consent form approved by the regulatory committees of both institutes and, obtained before each procedure related to the protocol, and that is not considered part of the normal care of the patient.
Able to comply with scheduled visits, treatment schedules, laboratory and imaging studies, and completing quality of life questionnaires.
Histological confirmation of CaCu and staged as IB3-IIIC1.
Patients with small-cell carcinoma or other rare histologies (glassy cell carcinoma, melanoma, sarcomas, lymphomas)
Patients with non-measurable disease.
Patients in whom pregnancy is confirmed during the recruitment procedure.
Clinical stages IIIC2-IVB.
Parallel
SABR VS Intracavitary 3D Brachytherapy
RadiationArm 1 will be the experimental arm and will consist of patients with CC clinical stages IB3-IIIC1 who will be treated with CT/RT with a minimum dose of 45Gy and boost in the case of macroscopic nodes (1.8Gy per fraction from Monday to Friday) with cisplatin and cervical boost with SBRT of 28Gy in 4 fractions administered at least every 40 hours to achieve an EQD210(Gy) at PTV D90% of 83.9Gy. Arm 2 will be the control arm that will consist of patients with CC clinical stages IB3-IIIC1 and will be treated with CT/RT with a minimum dose of 45Gy and boost in the case of macroscopic nodes (1.8Gy per fraction from Monday to Friday) with cisplatin and cervical boost with high-dose-rate 3D brachytherapy with a dose of 28Gy in 4 fractions administered at least every 40 hours to achieve an EQD210(Gy) at point A of 83.9Gy.
Acute Toxicity
It will be measured using the CTCAE V5.0 criteria.
Chronic Toxicity
It will be measured using the CTCAE V5.0 criteria.
General Health Perception
Quality of Life measured with the QLQ-C30 and QLQ-CX24 questionnaires validated in Mexican patients.
Local Control
Local efficacy and objective response using the RECIST 1.1 criteria.
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National Institute of Cancerología
Lead sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Collaborator
