Randomized Phase II Study to Measure the Safety and Efficacy of Concomitant CT/RT Followed by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma in Clinical Stage IB3-IIIC1 at INCAN
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.
• Squamous cell, adenosquamous, or adenocarcinoma histology.
• No prior treatment for cervical cancer.
• With disease measurable by CT, MRI, or PET/CT according to REC 1.1 criteria. This measurement must be carried out 28 days before randomization.
• Functional status of 0-2 according to WHO criteria.
• Charlson Comorbidity Index of 1-4
⁃ Candidates to receive cisplatin.
⁃ Normal hematological, kidney, and hepatic function according to:
⁃ Hematological:
⁃ Hemoglobin equal to or \>10g/L. (With the possibility of transfusion prior to treatment to reach this hemoglobin level).
⁃ Leukocytes \>4000/mm3. Platelets\>100,000mm3. Neutrophils \>1500 / μL
⁃ Hepatic:
⁃ Total bilirubin \<1.5 X times the normal value. Transaminases \<1.5 X times the normal value.
⁃ Renal:
⁃ Creatinine \<1.3mg/dl or creatinine clearance \> 40 mL/minute (using the Cockcroft/Gault formula).
⁃ Women: DepCr = (140 - Age in years) x Weight in kg x 0.85
⁃ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 72 x Serum Creatinine in mg/dL Men: DepCr = (140 - Age in years) x Weight in kg x 1.00
⁃ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 72 x Serum Creatinine in mg/dL
⁃ Chest tomography without metastatic disease or infectious diseases.
⁃ Negative pregnancy test in women of childbearing age.
⁃ Not a candidate for another clinical trial within the institution.