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

Ki vehet részt

• 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 >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
• 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

Ki nem vehet részt

• Concomitant treatment with another experimental drug
• 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
• 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)
• 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
• Patients with a percentage of rectal circumference receiving a dose of 15Gy >62.7%
• Patients with non-measurable disease
• Serious infections or diseases that can be reactivated with the use of chemotherapy or that could limit its use (hepatitis or HIV)
• 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
• 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
• 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
• Patients with small-cell carcinoma or other rare histologies (glassy cell carcinoma, melanoma, sarcomas, lymphomas)
• Patients in whom pregnancy is confirmed during the recruitment procedure
• Clinical stages IIIC2-IVB
• Pre-existing neuropathy of any etiology
• Any patient who is absent from follow-up for 5 subsequent appointments will be excluded from the study