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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Carcinoma, Adenocarcinoma, Uterine Cervix Adenosquamous Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control of disease

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Sergio Lago

Investigator Role:

Principal Investigator

Investigator Affiliation:

Núcleo de Novos Tratamentos em Câncer - NNTC

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

EF 110

NCT ID:

NCT01301612

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Carcinoma
  • Adenocarcinoma
  • Uterine Cervix Adenosquamous Carcinoma
  • carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Adenosquamous

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