Clinical trial NCT01345084: Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Carcinoma
Head and Neck Cancer
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Overall survival
timeFrame: 6 months
Secondary outcomes:
measure: Complete clinical response rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaetner
state: Paraná
city: porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Mogi das Cruzes
country: Brazil
facility: Centro Oncológico de Mogi das Cruzes
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso
city: São Paulo
country: Brazil
facility: Instituto do Câncer de São Paulo
Study officials:
affiliation: Hospital de Base São José do Rio Preto
name: Gustavo Girotto
role: PRINCIPAL_INVESTIGATOR
References: