Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

This is an interventional treatment trial for Cervical Cancer focused on measuring hypofractionated radiotherapy, Brachytherapy Read More

Inclusion Criteria:

• Women over 18 years old
• Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
• Histology: squamous, adenosquamous or adenocarcinoma
• No previous treatment
• No distance metastases, discard by Positron Emission Tomography (PET)/CT
• Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
• Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:
• Absolute neutrophil count ≥ 1,500 cell/mm3
• Platelets ≥ 100,000 cell/mm3
• Hemoglobin ≥ 10.0 g/dl
• Leukocyte count ≥ 4000 cell/mm3
• Adequate Renal Function defined as:
• Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study
• Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)
• The patient must understand the protocol and provide the specific informed consent of the study before admission
• Negative pregnancy test

Exclusion Criteria:

• Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
• Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
• Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
• Severe active or non-controlled co-morbidities, defined as:
• Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
• Transmural myocardial infarction in the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.
• Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.
• Crohn's disease or ulcerative colitis.
• Prior allergic reaction to cisplatin or other drugs based on platinum.
• Other factors that contraindicate experimental therapy.