Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

Head and Neck Cancer Clinical Trial

— NICAP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01345084
• Other study ID #: EF 118
• Status: Withdrawn
• Phase: Phase 3
• First received: April 28, 2011
• Last updated: July 24, 2015
• Start date: November 2013
• Est. completion date: November 2017

Study information

• Verified date: August 2013
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo
Brazil	Hospital Erasto Gaetner	Curitiba	Paraná
Brazil	Hospital Amaral Carvalho	Jau	São Paulo
Brazil	Centro Oncológico de Mogi das Cruzes	Mogi das Cruzes	São Paulo
Brazil	Hospital de Clínicas de Porto Alegre	porto Alegre	Rio Grande do Sul
Brazil	Hospital Federal de Bonsucesso	Rio de Janeiro
Brazil	Hospital de Base São José do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Instituto do Câncer de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.	6 months	Yes
Secondary	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;	2 years	Yes