Actively Recruiting
Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma
Led by National Institute of Cancerología · Updated on 2025-10-07
84
Participants Needed
1
Research Sites
345 weeks
Total Duration
On this page
Sponsors
N
National Institute of Cancerología
Lead Sponsor
N
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with cervical cancer older than 18 years
- Signed informed consent before protocol procedures
- Able to attend visits, treatments, tests, and complete quality of life questionnaires
- Histological confirmation of cervical cancer staged IB3 to IIIC1
- Squamous cell, adenosquamous, or adenocarcinoma types
- No prior cervical cancer treatment
- Measurable disease by CT, MRI, or PET/CT within 28 days before randomization
- Functional status 0 to 2 per WHO criteria
- Charlson Comorbidity Index between 1 and 4
- Eligible to receive cisplatin chemotherapy
- Normal blood counts: hemoglobin ≥10g/L, leukocytes >4000/mm3, platelets >100,000/mm3, neutrophils >1500/μL
- Normal liver function: bilirubin <1.5 times normal, transaminases <1.5 times normal
- Normal kidney function: creatinine <1.3 mg/dl or creatinine clearance >40 mL/min
- Chest CT scan showing no metastatic or infectious disease
- Negative pregnancy test if of childbearing potential
- Not enrolled in another clinical trial at the institution
You will not qualify if you...
- Small-cell carcinoma or rare histologies (glassy cell carcinoma, melanoma, sarcomas, lymphomas)
- Non-measurable disease
- Confirmed pregnancy during recruitment
- Clinical stages IIIC2 to IVB
- Serious infections like hepatitis or HIV or diseases limiting chemotherapy use
- Pre-existing neuropathy
- Receiving another experimental drug
- Severe mental illnesses or intellectual disabilities affecting study adherence
- Grade 3 obesity with BMI over 40 kg/m2
- Missing 5 consecutive follow-up appointments
- History of total or partial hysterectomy
- Prior neoadjuvant chemotherapy or use of antineoplastic drugs other than cisplatin
- History or planned use of Bevacizumab for cervical cancer
- Charlson Comorbidity Index over 5
- Synchronous cancers except non-melanoma skin cancer
- Prior pelvic radiation for other cancers
- Inflammatory bowel or collagen diseases
- Severe immunosuppression or transplant recipients
- Not signing informed consent
- Suspected alcohol or drug abuse
- Participation in other clinical trials within 90 days
- Any condition risking safety or protocol compliance as judged by researchers
- Rectal radiation dose exceeding specified limits
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancerologia
Mexico City, Tlalpan, Mexico
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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