Cervical cancer in stages IB2 and II.
Conditions
Interventions
Group I (Control)-Placebo: Chemoradiotherapy (CRT) consisting of cisplatin (40 mg / IMC) once a week as a radiosensitizer for 25 sessions of external radiotherapy, followed by two sessions of Brachyth
Chemoradiotherapy
Drug Therapy
Cisplatin
Brachytherapy
Peptides
Antineoplastic Agents
Placebos
CIGB-300
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients that meet the histological diagnostic criteria of squamous cell carcinoma or adenocarcinoma, stage IB2-II. 2) Patients with ECOG 0-1. 3) Informed consent signed by the patient. 4) Patients with normal hepatic, renal and hematological functions.
Exclusion criteria
Exclusion criteria: 1) Pregnancy and lactation. 2) Patients included in another clinical trial and who have received any biological therapy in research, including active or passive immunotherapy in the last 6 months. 3) Chronic decompensated diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental depression). 4) Allergic diseases (example, persistent bronchial asthma). 5) Acute infectious disease that prevents the application of the research product. 6) Diseases that compromise the patient's state of consciousness or their ability to give informed consent or collaborate in the trial. 7) Extensive tumor necrosis or endophytic tumor that prevents the application of the product as provided in this protocol. 8) Conditions that prevent the realization of high-field magnetic resonance imaging: cardiac pacemaker, implantable cardiac defibrillator; cochlear implant, vascular, metallic clips, vascular prosthesis, vascular stent, IUD, orthopedic prostheses, fragments of metals in the body (like projectiles of firearm), tattoos. 9) Use of intrauterine devices (IUDs), which contain copper. 10) Patients with claustrophobia (assess study under sedation). 11) Obese patients that exceed the limit of the gantry (tube) of the resonator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response (It will be evaluated according to the criteria of RECIST (Response evaluation criteria in solid tumors). Patients will be classified as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD)). Measurement time: at 3 and 6 months after end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to reach the clinical response (in weeks, according to the results of the clinical evaluation, digital rectal examination and digital colposcopy). Measurement time: at the beginning, in weeks 3 and 5 (before the first application of the research product) and in the 7th week (one week after the end of treatment). 2. Free survival of progression (in months, time from inclusion in the study to recurrence of the tumor or death from any cause). Measurement time: 24 months. 3. Overall survival (in months, Time from randomization until death from any cause). Measurement time: 24 months. 4. Quality of life (according to EORTC QLQ-C30 and QLQ-LC13). Measurement time: At baseline, 3 and 6 months, 9, 12, y 24 after treatment. 5. Biological variables (in plasma, numerical or qualitative values of predictive markers of response to CIGB-300, such as levels of protein B23 / PDL1 / CD4-CD8 / P16 and Ki-67, behavior of circulating tumor DNA, etc). Measurement time: at the beginning, at 24 hours, 7 days, 3 months and 6 months after treatment. 6. Adverse events (-Occurrence of adverse events (Yes, No) -Description of the adverse event (name of the event) -Intensity (mild, moderate, severe)). Measurement time: 24 hours after every administration of the intervention and, 3 months after treatment | — |
Countries
Cuba
Contacts
Public ContactIdania Baladron Castrillo
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed