The primary study objective will be to assess the efficacy of the combination of radiation therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC). The secondary study objectives will be safety and tolerability evaluations, to determine treatment feasibility and the interim efficacy evaluation according to other parameters routinely used in oncology.
This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study. The study will be conducted in Brazil and has the purpose of determining the activity and safety of nimotuzumab in terms of overall and distant disease-free survival, radiological and clinical gynecological examinations, as well as by biopsy, if indicated, progression-free survival, local control of long-term disease, frequency of treatment-emergent adverse events, frequency of severe treatment-emergent adverse events. All participating patients will sign a consent form before they undergo any study-related procedure.The eligible patients will have stage IB and IVA uterine cervical carcinoma and they will be randomized to one of two treatment groups. Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage (IB2 to IIIA versus IIIB to IVA), 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Nimotuzumab, 200 mg, IV, Weekly doses for 14 weeks
Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks
Brachytherapy: 40 Gy at spot A(low dose rate, Intracavitary, 1 or 2 separate fractions for 1 to 3 weeks. Brachytherapy: 28 Gy at spot A (high dose rate), Intracavitary 4 fractions of 7.0 Gy once or twice a week.
Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia
Ijuí, Rio Grande do Sul, Brazil
Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer
Porto Alegre, Rio Grande do Sul, Brazil
Caism - Unicamp
Local control of disease
Local control of disease will be measured by magnetic resonance imaging (MRI), clinical gynecological examinations, as well as by biopsy (if indicated), 12 weeks after treatment end.
Time frame: 1 year
Complete clinical response rate
* Overall survival; * Distant disease-free survival; * Progression-free survival; * Local control of long-term disease; Frequency of treatment-emergent adverse events; o Frequency of severe treatment-emergent adverse events.
Time frame: 3 years
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Cisplatin, 40 mg/m2, IV. Weekly doses for 6 weeks
Pelvic radiation therapy: 45 Gy, External, Fractions of 1.8 Gy per day, 5 days a week. Dose boosts: 15 Gy ± 5%, External, Daily fractions of 1.8 Gy or 2 Gy per day, 5 days a week. Brachytherapy 40 Gy at spot A(low dose rate.) Intracavitary 1 or 2 separate fractions for 1 to 3 weeks. 28 Gy at spot A (high dose rate, Intracavitary, 4 fractions of 7.0 Gy once or twice a week
Campinas, São Paulo, Brazil
Centro de Pesquisas Clínicas da Fundação Amaral Carvalho
Jaú, São Paulo, Brazil
ICESP
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil