New radiation technique could replace brachytherapy for cervical cancer
NCT ID NCT06560697
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a newer radiation technique called SABR with standard brachytherapy for treating locally advanced cervical cancer. About 84 women will receive either SABR or brachytherapy after initial chemo-radiation. The goal is to see if SABR is as safe and effective, which could help hospitals that lack brachytherapy equipment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (SABR or brachytherapy)
- What this could lead to
- If successful, this could provide an effective alternative to brachytherapy for cervical cancer, making treatment more accessible for hospitals without brachytherapy equipment.
- What could go wrong
- This is a phase 2 trial with only 84 participants, so results are preliminary. SABR may not be as effective or safe as brachytherapy, and long-term outcomes are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. People with cervical cancer \>18 years of age. 2. 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. 3. Able to comply with scheduled visits, treatment schedules, laboratory and imaging studies, and completing quality of life questionnaires. 4. Histological confirmation of CaCu and staged as IB3-IIIC1. 5. Squamous cell, adenosquamous, or adenocarcinoma histology. 6. No prior treatment for cervical cancer. 7. 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. 8. Functional status of 0-2 according to WHO criteria. 9. Charlson Comorbidity Index of 1-4 10. Candidates to receive cisplatin. 11. 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 12. Chest tomography without metastatic disease or infectious diseases. 13. Negative pregnancy test in women of childbearing age. 14. Not a candidate for another clinical trial within the institution. Exclusion Criteria: 1. Patients with small-cell carcinoma or other rare histologies (glassy cell carcinoma, melanoma, sarcomas, lymphomas) 2. Patients with non-measurable disease. 3. Patients in whom pregnancy is confirmed during the recruitment procedure. 4. Clinical stages IIIC2-IVB. 5. Serious infections or diseases that can be reactivated with the use of chemotherapy or that could limit its use (hepatitis or HIV). 6. Pre-existing neuropathy of any etiology. 7. Concomitant treatment with another experimental drug. 8. 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. 9. 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. 10. Any patient who is absent from follow-up for 5 subsequent appointments will be excluded from the study. 11. History of total or partial hysterectomy. 12. Patients with a history of neoadjuvant chemotherapy or use of another antineoplastic drug differ from cisplatin (40 mg/m2). 13. 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. 15\. 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). 20\. 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. 23\. Any illness or disability not covered by the exclusion criteria that, in the researchers' opinion, may put the patient's safety and compliance with the protocol at risk. 24\. Patients with a percentage of rectal circumference receiving a dose of 15Gy \>62.7%
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Instituto Nacional de Cancerologia
RECRUITINGMexico City, Tlalpan, Mexico
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Other studies related to the condition(s) this trial covers.
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- Chlorophyll-Based supplement may ease radiation damage in cervical cancer patients