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Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)

Primary Purpose

Carcinoma, Adenocarcinoma, Uterine Cervix Adenosquamous Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Nimotuzumab
Cisplatin
Brachytherapy
Cisplatin
Radiation Therapy
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer
  • Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia
  • Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer
  • Caism - Unicamp
  • Centro de Pesquisas Clínicas da Fundação Amaral Carvalho
  • ICESP
  • Hospital Santa Marcelina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiation therapy and Cisplatin

Nimotuzumab and

Arm Description

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 (if indicaed), 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.

Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks. Nimotuzumab, 200 mg, Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes, Weekly doses for 14 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 (In case there is indication, should it be performed, not to be longer than the expected 70 days for the entire radiation therapy), 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 21, 2011
Last Updated
July 10, 2014
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01301612
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Regulatory requirement. A phase III study is being designed.
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Adenocarcinoma, Uterine Cervix Adenosquamous Carcinoma
Keywords
carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy and Cisplatin
Arm Type
Active Comparator
Arm Description
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 (if indicaed), 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.
Arm Title
Nimotuzumab and
Arm Type
Experimental
Arm Description
Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks. Nimotuzumab, 200 mg, Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes, Weekly doses for 14 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 (In case there is indication, should it be performed, not to be longer than the expected 70 days for the entire radiation therapy), 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.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
Nimotuzumab, 200 mg, IV, Weekly doses for 14 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin, 40 mg/m2, IV. Weekly doses for 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Local control of disease
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complete clinical response rate
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Lago
Organizational Affiliation
Núcleo de Novos Tratamentos em Câncer - NNTC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer
City
Natal
State/Province
Rio Grande do Norte
ZIP/Postal Code
59075740
Country
Brazil
Facility Name
Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia
City
Ijui
State/Province
Rio Grande do Sul
ZIP/Postal Code
98700000
Country
Brazil
Facility Name
Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90020-160
Country
Brazil
Facility Name
Caism - Unicamp
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083970
Country
Brazil
Facility Name
Centro de Pesquisas Clínicas da Fundação Amaral Carvalho
City
Jau
State/Province
São Paulo
ZIP/Postal Code
17210000
Country
Brazil
Facility Name
ICESP
City
São Paulo
ZIP/Postal Code
01246000
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
São Paulo
ZIP/Postal Code
08270070
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)

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