Actively Recruiting
Randomized Phase II Study Comparing Safety and Efficacy of Chemotherapy/Radiotherapy Followed by Ablative Stereotactic Radiotherapy Versus Brachytherapy in Women With Cervical Carcinoma Stages IB3 to IIIC1
Led by National Institute of Cancerología · Updated on 2025-10-07
84
Participants Needed
1
Research Sites
156 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
Cervical cancer is a leading cause of death among women, particularly those with locally advanced disease stages. This trial investigates whether stereotactic body radiotherapy (SBRT) can be as safe and effective as the standard brachytherapy boost when combined with chemotherapy and radiotherapy in treating cervical cancer stages IB3 to IIIC1. The study aims to provide new treatment options for patients, especially where brachytherapy is less accessible. Participants are randomly assigned to one of two treatment groups: one receiving chemotherapy and radiotherapy followed by SBRT as a boost, and the other receiving chemotherapy and radiotherapy followed by high-dose-rate 3D intracavitary brachytherapy. Both groups receive a minimum radiation dose of 45 Gy with cisplatin, and the boost dose is delivered in 4 fractions at intervals of at least 40 hours to achieve a comparable total dose. The study focuses on comparing these two radiation boost methods. Throughout the study, participants undergo scheduled visits, imaging tests like CT or MRI scans, laboratory exams, and complete quality of life questionnaires. Researchers monitor safety using acute and chronic toxicity criteria, assess local disease control, overall and progression-free survival, and track quality of life over five years. The study includes thorough follow-up to evaluate treatment outcomes and side effects, lasting up to five years from treatment start.
CONDITIONS
Brief 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 aged 18 years or older with cervical cancer.
- Signed informed consent obtained before study procedures.
- Able to attend scheduled visits, treatments, labs, imaging, and complete quality of life questionnaires.
- Histological confirmation of cervical cancer staged IB3 to IIIC1.
- Squamous cell, adenosquamous, or adenocarcinoma histology.
- No prior treatment for cervical cancer.
- Disease measurable by CT, MRI, or PET/CT within 28 days before randomization.
- Functional status of 0 to 2 according to WHO criteria.
- Charlson Comorbidity Index between 1 and 4.
- Eligible to receive cisplatin chemotherapy.
- Normal blood counts: hemoglobin ≥10 g/L, leukocytes >4000/mm3, platelets >100,000/mm3, neutrophils >1500/µL.
- Normal liver function: total 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 showing no metastatic or infectious disease.
- Negative pregnancy test for women of childbearing age.
- Not participating 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 or diseases limiting chemotherapy use (e.g., hepatitis, HIV).
- Pre-existing neuropathy.
- Concurrent treatment with another experimental drug.
- Severe mental illnesses or conditions limiting study adherence.
- Grade 3 obesity (BMI >40 kg/m2).
- Absence from follow-up for 5 consecutive appointments.
- History of total or partial hysterectomy.
- Previous neoadjuvant chemotherapy or use of antineoplastic drugs other than cisplatin.
- Prior or planned use of Bevacizumab unrelated to cervical cancer treatment.
- Charlson Comorbidity Index greater than 5.
- Synchronous cancers except non-melanoma skin cancer.
- History of pelvic irradiation for other cancers.
- Inflammatory bowel or collagen diseases.
- Severe immunosuppression (transplant or immunosuppressive treatment).
- Failure to sign informed consent.
- Suspected alcohol or recreational drug abuse.
- Participation in another clinical trial within 90 days prior.
- Any other illness or disability risking safety or protocol compliance.
- Rectal dose exposure exceeding specified limits.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 6 weeks
Participants receive chemotherapy and radiotherapy with a minimum dose of 45Gy and boost for macroscopic nodes, followed by a cervical boost either with stereotactic ablative radiotherapy (SABR) or high-dose-rate 3D intracavitary brachytherapy.
Weekly visits for radiotherapy Monday to Friday; 4 boost fractions administered at least every 40 hours
Duration - Up to 5 years
Participants are monitored for acute and chronic toxicity, local control, overall survival, progression-free survival, and quality of life for up to 5 years after treatment.
Regular follow-up visits as scheduled over 5 years
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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