Carcinoma, Head and Neck Cancer
Conditions
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
Interventions
RADIATIONRadiation Therapy
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
DRUGNimotuzumab
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).
DRUGCisplatin
75 mg/m2, IV, doses every 3 weeks (a total of three doses)
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6 months | Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical response rate | 2 years | 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; |
Countries
Brazil
Outcome results
None listed