Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.

Sex

Female

Minimum age

18 Years

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.

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