Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Cisplatin; Nimotuzumab

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.