Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation
- Stages IIA and IIB FIGO classification.
- Age between 21 to 70 years.
- ECOG performance status 0-1.
- No history of another neoplastic disease.
- Value of Hemoglobin ≥ 9 g / l.
- Total leukocyte count ≥ 3.0 x 109 / L.
- Absolute neutrophil count ≥ 1.5 x 109 / L.
- Platelets ≥ 100,000 x mm3.
- Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
- Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to
- Patients of childbearing age who are using an adequate contraception method during
treatment to prevent pregnancy.
- Life expectancy ≥ 12 months
- Measurable disease
- Informed consent signed by the patient
- Pregnancy and lactation period.
- Presence of lymph node metastases or hematogenous extrapelvic known.
- Uncontrolled intercurrent diseases, including active infection, symptomatic
congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric
illness involving incompetence of the patient.
- Other malignancies, with the exception of basal cell carcinoma or other tumor that
appropriate treatment is received showing a disease-free period ≥ 5 years.
- Hepatitis B or C active, positive serology for HIV.
- Atopy history of severe / severe asthma.
- A history of autoimmune disease.
- Presence of significant abnormalities in ECG performed within 14 days prior to
- Diseases that prevent the patient give informed consent or their ability to
collaborate in the trial.
- Participating in another clinical trial "