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New radiation technique could replace brachytherapy for cervical cancer

NCT ID NCT06560697

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

cervical cancer Uterine Cervical Neoplasms

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Instituto Nacional de Cancerologia

    RECRUITING

    Mexico City, Tlalpan, Mexico

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