Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma

Launched by NATIONAL INSTITUTE OF CANCEROLOGÍA · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different methods of treating cervical cancer: Ablative Stereotactic Radiotherapy (SABR) and traditional Brachytherapy. Both treatments are used after chemotherapy and radiation therapy to boost the effectiveness of the initial treatment. The researchers want to find out if SABR is just as safe and effective as Brachytherapy for women with locally advanced cervical cancer. This is important because many hospitals may not have access to Brachytherapy or have long waiting lists for it.

To participate in the trial, women over 18 years old, diagnosed with specific stages of cervical cancer (IB3-IIIC1), need to meet certain health criteria. They should not have had previous treatments for cervical cancer and must be able to follow through with scheduled visits and treatments. Participants can expect to receive either SABR or Brachytherapy, along with the standard chemotherapy, and their health and quality of life will be monitored throughout the study. This trial could lead to new treatment options for patients who face challenges accessing traditional therapies.

Gender

FEMALE

Eligibility criteria

• 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%