CarcinomaPhase 3NICAPNCT01345084
Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
A Phase 3 study testing Radiation Therapy, Nimotuzumab and Cisplatin in people with Carcinoma and Head and Neck Cancer, run by Eurofarma Laboratorios S.A. at 8 sites in Brazil.
Trial summary
Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups. Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Head and Neck Cancer
- What is being tested?
- Radiation Therapy, Nimotuzumab and Cisplatin
- 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
- 8 sitesBrazil
- Study dates
- Nov 2013to Nov 2017
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old;
- Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
- Stages III or IV disease
- Unresectability according to responsible surgeon or medical staff's opinion;
- Performance status 0 or 1
- Present indication for radiation therapy and chemotherapy treatment with cisplatin;
- Adequate hepatic, renal and medullar functions, indicated by:
- Life expectancy above 6 months.
Who cannot join
- Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
- Presence of known distant metastasis;
- Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
- Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
- Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
- Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance;
Show all 13Show fewer
- Active known seropositivity for HIV, hepatitis B or C
- Presence of a significant neurological or psychiatric disease, as per the investigator's judgment;
- Hypersensitivity or allergy to any of the study treatments;
- Presence of uncontrolled hypercalcemia;
- Pregnancy or breastfeeding;
- Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period;
- Participation in any clinical trial in the last 12 months.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400
Hospital Erasto Gaetner
Curitiba, Paraná, 81520-060
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120
Centro Oncológico de Mogi das Cruzes
Mogi das Cruzes, São Paulo, 08730-500
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 210041-030
Hospital de Base São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Instituto do Câncer de São Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck
Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.
Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.
Read the detailed description
This is a phase III, superiority, national, open-label, randomized, and two-arm study.
Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.
All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1
- Conditions
- Carcinoma, Head and Neck Cancer
- Being tested
- Radiation Therapy, Nimotuzumab, Cisplatin
- Medical subject headings
- Carcinoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
NimotuzumabDrug
200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).
CisplatinDrug
75 mg/m2, IV, doses every 3 weeks (a total of three doses)
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy, cisplatin and nimotuzumab | Experimental | Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months.
Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week
Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses) Receives: Drug: Nimotuzumab |
| Radiation therapy and cisplatin | Active comparator | Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week
Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses) Receives: Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
Measured: 6 months
Secondary outcomes (1)
Complete clinical response rate
Progression-free survival; Incidence of locoregional failure; Site of the first recurrence or progression; Objective response rate assessment; EORTC quality of life questionnaires assessment; Incidence of several adverse events;
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startNov 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: change company strategy
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 3
- 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
- Gustavo Girotto, Principal investigator, Hospital de Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345084
- Sponsor's protocol ID
- EF 118
- Acronym
- NICAP
- Status last verified
- Aug 2013
- First submitted
- 28 Apr 2011
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT01345084
- Acronym / sponsor ID
- NICAP / EF 118
- Conditions
- Carcinoma, Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 29 Apr 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.
Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.
Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.
Detailed description
This is a phase III, superiority, national, open-label, randomized, and two-arm study.
Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.
All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 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, cisplatin and nimotuzumab | Experimental | Drug: NimotuzumabNimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months. Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses) |
| Radiation therapy and cisplatin | Active comparator | Radiation: Radiation Therapy, Drug: CisplatinRadiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 75 years old;
- Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
- Stages III or IV disease
- Unresectability according to responsible surgeon or medical staff's opinion;
- Performance status 0 or 1
Key exclusion criteria (13 listed)
- Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
- Presence of known distant metastasis;
- Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
- Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
- Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
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 |
|---|---|---|
| Radiation Therapy66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week | Radiation | Radiation therapy and cisplatin |
| Nimotuzumab200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes). | Drug | Radiation therapy, cisplatin and nimotuzumab |
| Cisplatin75 mg/m2, IV, doses every 3 weeks (a total of three doses) | Drug | Radiation therapy and cisplatin |
Primary outcome
Overall survival
Time frame: 6 months
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
1 secondary outcome
Complete clinical response rate
Time frame: 2 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 28 Mar 2025.
Related trials for Carcinoma
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
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.
Gustavo Girotto principal investigator
Hospital de Base
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation Therapy, Nimotuzumab and Cisplatin in people with Carcinoma and Head and Neck Cancer, run by Eurofarma Laboratorios S.A. at 8 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 8 inclusion and 13 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall survival (time frame: 6 months). 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 28 Mar 2025.