CarcinomaPhase 2NCT01301612
Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)
A Phase 2 study testing Nimotuzumab, Cisplatin and Brachytherapy in people with Carcinoma and Adenocarcinoma, run by Eurofarma Laboratorios S.A. at 7 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Adenocarcinoma, Uterine Cervix Adenosquamous Carcinoma
- What is being tested?
- Nimotuzumab, Cisplatin and Brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesBrazil
- Study dates
- Jan 2011to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Brazil7 sites
Caism - Unicamp
Campinas, São Paulo, 13083970
Hospital de Caridade de Ijui - ONCOSITE Centro de Pesquisa Clínica em Oncologia
Ijuí, Rio Grande do Sul, 98700000
Centro de Pesquisas Clínicas da Fundação Amaral Carvalho
Jaú, São Paulo, 17210000
Centro de Pesquisa Clínica da Liga Norte Riograndense contra o Câncer
Natal, Rio Grande do Norte, 59075740
Hospital Santa Rita - Núcleo de Novos Tratamentos em Câncer
Porto Alegre, Rio Grande do Sul, 90020-160
ICESP
São Paulo, São Paulo, 01246000
Hospital Santa Marcelina
São Paulo, São Paulo, 08270070
About this study
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
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.
Read the 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.
- Being tested
- Nimotuzumab, Cisplatin, Brachytherapy, Radiation Therapy
- Keywords
- carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma
- Medical subject headings
- Carcinoma, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Nimotuzumab, 200 mg, IV, Weekly doses for 14 weeks
CisplatinDrug
Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks
BrachytherapyRadiation
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.
CisplatinDrug
Cisplatin, 40 mg/m2, IV. Weekly doses for 6 weeks
Radiation TherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy and Cisplatin | Active comparator | 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. Receives: Drug: Cisplatin; Radiation: Radiation Therapy |
| Nimotuzumab and | Experimental | 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. Receives: Drug: Nimotuzumab; Drug: Cisplatin; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2017 (estimated)
Why it stopped: Regulatory requirement. A phase III study is being designed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio Lago, Principal investigator, Núcleo de Novos Tratamentos em Câncer - NNTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301612
- Sponsor's protocol ID
- EF 110
- Status last verified
- Jan 2012
- First submitted
- 21 Feb 2011
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01301612
- Acronym / sponsor ID
- EF 110
- Keywords
- carcinoma or adenocarcinoma or uterine cervix adenosquamous carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory requirement. A phase III study is being designed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2017 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy and Cisplatin | Active comparator | Drug: Cisplatin, Radiation: Radiation TherapyCisplatin, 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. |
| Nimotuzumab and | Experimental | Drug: Nimotuzumab, Drug: Cisplatin, Radiation: BrachytherapyCisplatin, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimotuzumabNimotuzumab, 200 mg, IV, Weekly doses for 14 weeks | Drug | Nimotuzumab and |
| CisplatinCisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks | Drug | Nimotuzumab and |
| BrachytherapyBrachytherapy: 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. | Radiation | Nimotuzumab and |
| CisplatinCisplatin, 40 mg/m2, IV. Weekly doses for 6 weeks | Drug | Radiation therapy and Cisplatin |
| Radiation TherapyPelvic 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 | Radiation | Radiation therapy and Cisplatin |
Primary outcome
Local control of disease
Time frame: 1 year
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.
1 secondary outcome
Complete clinical response rate
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Lago principal investigator
Núcleo de Novos Tratamentos em Câncer - NNTC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab, Cisplatin and Brachytherapy in people with Carcinoma and Adenocarcinoma, run by Eurofarma Laboratorios S.A. at 7 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control of disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.