Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

NCT01345084 | Withdrawn Phase 3

• 1 other identifier: EF 118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Carcinoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complete clinical response rate

  2 years

Study Arms (2)

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)

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)

Radiation: Radiation Therapy; Drug: Cisplatin

Interventions

Radiation Therapy RADIATION

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

Radiation therapy and cisplatin

Nimotuzumab DRUG

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).

Radiation therapy, cisplatin and nimotuzumab

Cisplatin DRUG

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

Radiation therapy and cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (8)

Hospital Erasto Gaetner

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital Federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, 210041-030, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

Centro Oncológico de Mogi das Cruzes

Mogi das Cruzes, São Paulo, 08730-500, Brazil

Location

Hospital de Base São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto do Câncer de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Carcinoma; Head and Neck Neoplasms

Interventions

Radiotherapy; nimotuzumab; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gustavo Girotto

  Hospital de Base São José do Rio Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2017
• Last Updated: March 28, 2025

Record last verified: 2013-08

Locations

BR (8)