Clinical trial NCT01301612: Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)
Official title: A Phase II, Multicenter, Randomized,Two-Arm Clinical Study: An Investigational Arm Containing Nimotuzumab in Combination With Radiotion Therapy and Cisplatyn, and a Control Arm With Radiation Therapy and Cisplatin for the Definitive Treatment of Stage IB and IVA Uterine Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carcinoma
Adenocarcinoma
Uterine Cervix Adenosquamous Carcinoma
Keywords: carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Diagnosis of histologically confirmed stages IB2 (\> 4 cm) to IVA prickle-cell carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma, according to FIGO system,7 (see Appendix A for guidance about staging);
* Measurable disease according to RECIST 1.139 or at least disease evaluable through imaging methods and/or gynecological examination (magnetic resonance imaging (MRI) scans within six weeks prior to randomization will be accepted, computed tomography will accepted in case MRI is contraindicated);
* Indication of definitive treatment with chemotherapy and radiation therapy, at the investigator's discretion;
* Performance status \< 2, according to the Eastern Cooperative Oncology Group criteria 40 (ECOG; see Appendix C);
* Adequate body functions, indicated by:Serum creatinine \< 1.2 mg/100 mL; Creatinine clearance \> 60 mL/min (estimate); Bilirubin up to 1.5-fold the upper limit of normal (ULN) and transaminases, alkaline phosphatase and gamma-glutamyltransferase up to 2.5-fold the ULN; Leucocytes \> 3,000/μL; Neutrophils \> 1,500/μL; Hemoglobin \> 10 g/dL; Platelets \> 80,000/μL;
* Signed informed consent form.

Exclusion Criteria:

* Para-aortic lymph nodes involvement through radiological and/or surgical staging, at investigator's discretion;
* Current severe comorbidity that, in the investigator's opinion, would put the patient at a significantly higher risk or will jeopardize protocol compliance;
* Current bowel inflammatory disease;
* Current major neurological or psychiatric disease, including clinically significant dementia and seizures, at the investigator's discretion;
* Known hypersensitivity or allergic reactions to study treatment;
* Current uncontrolled hypercalcemia (\> 11,5 mg/dL, that is, grade \> 1 according to Common Terminology Criteria for Adverse Events \[CTCAE\] v4.02, of US National Cancer Institute)41;
* Know HIV positive status (enrollment of patients with hepatitis B or C is at the investigator's discretion);
* Pregnancy or lactation;
* Female patients, as well as their partners, who wish to become pregnant or are unwilling to use an appropriate contraceptive method throughout the study period.

Primary outcomes:
measure: Local control of disease
timeFrame: 1 year
Secondary outcomes:
measure: Complete clinical response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer
state: Rio Grande do Norte
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer
state: Rio Grande do Sul
city: Campinas
country: Brazil
facility: Caism - Unicamp
state: São Paulo
city: Jau
country: Brazil
facility: Centro de Pesquisas Clínicas da Fundação Amaral Carvalho
state: São Paulo
city: São Paulo
country: Brazil
facility: ICESP
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
Study officials:
affiliation: Núcleo de Novos Tratamentos em Câncer - NNTC
name: Sergio Lago
role: PRINCIPAL_INVESTIGATOR
References: