Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma
NCT Number: NCT06560697
Acronym: SABRVICAL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Cervical Neoplasm
Interventions: RADIATION: SABR VS Intracavitary 3D Brachytherapy
Sponsor: National Institute of Cancerología
Collaborators: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2030-12-31
Locations: Instituto Nacional de Cancerologia, Mexico City, Tlalpan, Mexico

Summary:
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.

Primary Outcome Measures: Acute Toxicity, It will be measured using the CTCAE V5.0 criteria., 5 years|Chronic Toxicity, It will be measured using the CTCAE V5.0 criteria., 5 years
Secondary Outcome Measures: General Health Perception, Quality of Life measured with the QLQ-C30 and QLQ-CX24 questionnaires validated in Mexican patients., 5 years|Local Control, Local efficacy and objective response using the RECIST 1.1 criteria., 5 years