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Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab (NICAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345084
Recruitment Status : Withdrawn (change company strategy)
First Posted : April 29, 2011
Last Update Posted : July 27, 2015
Information provided by:
Eurofarma Laboratorios S.A.

Brief 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, quality of life assessment and incidence of adverse events.

Condition or disease Intervention/treatment Phase
Carcinoma Head and Neck Cancer Radiation: Radiation Therapy Drug: Nimotuzumab Drug: Cisplatin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Radiation therapy, cisplatin and nimotuzumab

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)

Drug: Nimotuzumab
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).

Active Comparator: Radiation therapy and cisplatin

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)

Radiation: Radiation Therapy
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week

Drug: Cisplatin
75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Complete clinical response rate [ Time Frame: 2 years ]
    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;

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345084

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Hospital Erasto Gaetner
Curitiba, Paraná, Brazil, 81520-060
Hospital de Clínicas de Porto Alegre
porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Hospital Amaral Carvalho
Jau, São Paulo, Brazil, 17210-120
Centro Oncológico de Mogi das Cruzes
Mogi das Cruzes, São Paulo, Brazil, 08730-500
Hospital de Base São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Hospital Federal de Bonsucesso
Rio de Janeiro, Brazil, 210041-030
Instituto do Câncer de São Paulo
São Paulo, Brazil, 01246-000
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
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Principal Investigator: Gustavo Girotto Hospital de Base São José do Rio Preto
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Responsible Party: Fernanda Martinez, Eurofarma Laboratórios Identifier: NCT01345084    
Other Study ID Numbers: EF 118
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: August 2013
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antineoplastic Agents, Immunological