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Compares treatment options for Uterine Cervical Neoplasm
Official title Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma
ClinicalTrials.gov ID: NCT06560697
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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.
You likely can't join 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.
See the full eligibility criteria
- 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...
- Chest tomography without metastatic disease or infectious diseases.
- Negative pregnancy test in women of childbearing age.
- Not a candidate for another clinical trial within the institution.
- 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...
- 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...
- 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. 15\. Charlson Comorbidity Index \>5 16. Synchronous Cancer except non-melanoma Skin Cancer...
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Tlalpan, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Tlalpan, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.