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

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.

Study Overview

• Status: Withdrawn
• Conditions: Carcinoma; Head and Neck Cancer
• Intervention / Treatment: Drug: Nimotuzumab; Radiation: Radiation Therapy; Drug: Cisplatin

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 210041-030
    • Hospital Federal de Bonsucesso
  • São Paulo, Brazil, 01246-000
    • Instituto do Câncer de São Paulo
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Hospital Erasto Gaetner
  • Rio Grande do Sul
    • porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • Jau, São Paulo, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • Mogi das Cruzes, São Paulo, Brazil, 08730-500
      • Centro Oncológico de Mogi das Cruzes
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base São José do Rio Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: Gustavo Girotto, Hospital de Base São José do Rio Preto

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Estimated): November 1, 2013
• Study Completion (Estimated): November 1, 2017

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimated): April 29, 2011

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Nimotuzumab
• Other Study ID Numbers: EF 118