Uterine cervical carcinoma stage IIB to IVA
Conditions
Interventions
Two arms:
177 patients will be randomized by internet in validated electronic system (CRFe) to the investigational arm with nimotuzumab I.V. 200mg/week per 16 weeks in combination with radiation thera
Drug
Biological/vaccine
Radiation
E02.319
Sponsors
Eurofarma Laboratórios S.A.
Eurofarma Laboratórios S.A.
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Be 18 years of age or older; have a histologically confirmed diagnosis of stage IIB to IVA squamous cell carcinoma, or adenocarcinoma, or cervical adenosquamous carcinoma, according to the IFGO system; life expectancy longer than 12 weeks; have measurable disease, according to the RECIST 1.1 criteria, or at least assessable by imaging and/or gynecological examination (imaging from up to six weeks prior to randomization will be accepted); indication for definitive treatment with chemotherapy and radiation therapy, according to the investigator’s opinion; performance status ? 2, according to the ECOG criteria; adequate bodily functions; have signed the informed consent form.
Exclusion criteria
Exclusion criteria: Involvement of para-aortic lymph nodes, by radiological and/or surgical staging, according to the investigator’s opinion; presence of severe co-morbidities, which – according to the opinion of the investigator – will put the patient at a significantly higher risk or will impair compliance with the protocol; presence of neurological or psychiatric diseases or other significant conditions compromising compliance; known hypersensitivity or allergy to the study treatments; non-controlled hypercalcemia (> 11.5 mg/dL, i.e., grade > 1 according to CTCAE v4.02, of the American National Cancer Institute); known seropositivity to HIV; known and active hepatitis B or C; pregnant or lactating patients; patients – and their partners – refusing to use a proper contraceptive method during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), measured by radiological and clinical-gynecological examinations, as well as by biopsy, if indicated, performed 10 weeks after treatment end, and assessed at the response evaluation visit (RE) and every 12 (±2) weeks during two years. The RECIST 1.1 criteria will be used to measure tumor progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival will be measured from treatment start to death. Disease-free survival in 2 years will be measured from treatment start to the date of the first imaging scan with registered distant lesion or patient death. Objective response and objective response rate according to radiological and clinical examinations Recurrence-free survival in 2 years. Local control of disease in 2 years according to radiological examination and will follow the algorithm for the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Frequency of treatment-emergent adverse events. Frequency of severe treatment-emergent adverse events, according case report form registry. Quality of life according to the QLQ-C30 and QLQ-CX24 (EORTC) questionnaires. | — |
Countries
Brazil
Contacts
Public ContactSuely Inoue
Eurofarma Laboratórios S.A.
Outcome results
None listed