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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Eurofarma Laboratorios S.A.
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01345084
First received: April 28, 2011
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Carcinoma
Head and Neck Cancer
Radiation: Radiation Therapy
Drug: Nimotuzumab
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.


Secondary Outcome Measures:
  • Complete clinical response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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;


Estimated Enrollment: 280
Study Start Date: November 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345084

Contacts
Contact: Kamila Silva Caldeira 55 17 9 -8119-4244 oncofamerp@yahoo.com.br

Locations
Brazil
Hospital Erasto Gaetner Not yet recruiting
Curitiba, Paraná, Brazil, 81520-060
Contact: Jeanine Nardin    51 3361-5133    pesquisa@lpcc.org.br   
Principal Investigator: Fabricio Oliveira         
Hospital de Clínicas de Porto Alegre Not yet recruiting
porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Gabriela Remedi    55 3359-8619    gremedi@hcpa.ufgrs.br   
Principal Investigator: Sergio Azevedo         
Fundação Pio XII - Hospital de Câncer de Barretos Not yet recruiting
Barretos, São Paulo, Brazil, 14784-400
Contact: Luciano Viana    3321-6637      
Principal Investigator: Luciano Viana         
Hospital Amaral Carvalho Not yet recruiting
Jau, São Paulo, Brazil, 17210-120
Contact: Daniela Gonçalves    14 3602- 1397    danielazanotti@amaralcarvalho.org.br   
Principal Investigator: Jose Segalla         
Centro Oncológico de Mogi das Cruzes Not yet recruiting
Mogi das Cruzes, São Paulo, Brazil, 08730-500
Contact: Camila Oliveira    4597-4597    camilagalvao@centrooncologico.com.br   
Principal Investigator: Daniel Grabarz         
Hospital de Base São José do Rio Preto Not yet recruiting
São José do Rio Preto, São Paulo, Brazil, 15090-000
Contact: Kamylla Caldeira    17 3201-5000 ext 1486    oncofamerp@yahoo.com.br   
Principal Investigator: Gustavo Girotto         
Hospital Federal de Bonsucesso Not yet recruiting
Rio de Janeiro, Brazil, 210041-030
Contact: Roberta Caboclo    21 9805-2462    robertacaboclo@gmail.com   
Principal Investigator: Bruno França         
Instituto do Câncer de São Paulo Not yet recruiting
São Paulo, Brazil, 01246-000
Contact: Suleima Jokh    11 3893-2617    suleima.jokh@icesp.org.br   
Principal Investigator: Gilberto Nunes         
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
Principal Investigator: Gustavo Girotto Hospital de Base São José do Rio Preto
  More Information

No publications provided

Responsible Party: Fernanda Martinez, Eurofarma Laboratórios
ClinicalTrials.gov Identifier: NCT01345084     History of Changes
Other Study ID Numbers: EF 118
Study First Received: April 28, 2011
Last Updated: August 15, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014