Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma

NCT06560697 | Recruiting DMC

• 1 other identifier: (023/044/ICI) (CEI/016/23)
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• General Health Perception

  5 years

• Local Control

  5 years

Study Arms (2)

Cervical Boost with SABR

EXPERIMENTAL

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

Radiation: SABR VS Intracavitary 3D Brachytherapy

Cervical Boost with Intracavitary Brachytherapy

ACTIVE COMPARATOR

Patients with CC clinical stages IB3-IIIC1 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.

Radiation: SABR VS Intracavitary 3D Brachytherapy

Interventions

SABR VS Intracavitary 3D Brachytherapy RADIATION

Arm 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.

Cervical Boost with Intracavitary Brachytherapy; Cervical Boost with SABR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People with uterine cervix carcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• Serious infections or diseases that can be reactivated with the use of chemotherapy or that could limit its use (hepatitis or HIV).
• Pre-existing neuropathy of any etiology.
• Concomitant treatment with another experimental drug.
• Mental illnesses: With the intention of maximizing adherence to the study, those patients who are at risk of imminent physical aggression (evident during the interview), have intellectual disabilities or autism, and who come for consultation due to coercion will not be included in the study. their accompanying Severe major depressive disorder, with or without psychotic symptoms; patients in whom a psychiatric diagnosis coexists in addition to the abuse of some recreational substance, eating disorders, schizophrenia, or Bipolar-type Schizoaffective Disorder.
• Grade 3 obesity with body mass index \>40kg/m2 according to the World Health Organization: Patients treated with pelvic radiotherapy and a body mass index \>40kg/m2 are associated with a decrease in quality of life due to sexual, intestinal, genitourinary alterations, as well as greater toxicity due to oncological treatments offered such as intracavitary brachyter in which the positioning of the equipment in the vaginal area is significantly difficult in sedated patients. Patients with grade III obesity will not be included.
• Any patient who is absent from follow-up for 5 subsequent appointments will be excluded from the study.
• History of total or partial hysterectomy.
• Patients with a history of neoadjuvant chemotherapy or use of another antineoplastic drug differ from cisplatin (40 mg/m2).
• History of use of Bevacizumab to manage a pathology other than CC or intention to use this drug as part of the treatment of CC.
• \. Charlson Comorbidity Index \>5 16. Synchronous Cancer except non-melanoma Skin Cancer. 17. History of pelvic irradiation for metachronous cancer. 18. Inflammatory bowel disease or collagen diseases. 19. Patients with severe immunosuppression (transplant or treatment with immunosuppressive drugs).
• \. Patients who do not sign the informed consent form. 21. Suspected alcohol or recreational drug abuse. 22. Participation in any other clinical trial in the last 90 days prior to protocol recruitment.

Sponsors & Collaborators

• National Institute of Cancerología: lead
• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: collaborator

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Tlalpan, Mexico

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized open-label phase 2 study in people with CaCu clinical stages IB3-IIIC1 treated with QT/RT. Subjects will be randomized to cervical boost with SBRT or 3D intracavitary brachytherapy in a 1:1 ratio and stratified by nodal status.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 19, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

ME (1)