CERVICONC-II-300 study

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 144

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures