A Phase III, Open-label Study Comparing Radiation Therapy Alone and Radiation Therapy in Combination With Nimotuzumab, Both After Induction Chemotherapy in Locally Advanced and Unresectable Head and Neck Cancer
Inclusion Criteria:
In order to be enrolled in this study, eligible patients must meet all criteria below:
- ICF signing
- Aged 18 to 70 years old;
- Histological or cytological confirmation of SCC in oral cavity, oropharynx,
hypopharynx, or larynx;
- Stage III or IV disease, as per 6th edition of TNM 13 classification;
- Unresectability according to surgeon or medical staff's opinion;
- Performance status 0 or 1, according to the Eastern Cooperative Oncology Group scale
(ECOG),65 in Appendix B;
- Adequate body function, indicated by:
- Serum creatinine ≤1,2 mg/dL;
- Bilirubin, transaminase, and alkaline phosphatase < 1.5 x the upper limit of normal
(ULN);
- Leucocytes ≥3,000/mm3;
- Granulocytes ≥1,500/mm3;
- Hemoglobin > 10 g/dL;
- Platelets > 100,000/mm3;
- Life expectancy above 6 months.
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible for the study:
- Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
- Presence of distant metastasis demonstrated by any clinical or radiographic method;
- Presence of any other active neoplasm or history of any tumor diagnosed in the last 5
years, except for basal cell carcinoma or skin SCC, and except for skin, breast,
bladder, cervix, or anal canal carcinomas in situ (these tumors do not prevent
participation if already treated, even though in the last 5 years);
- Presence of SCC cervical metastasis of unknown primary origin 16;
- Weighted loss above 20% in the last 3 months 14;
- Inability to eat without gastric or enteral tube (in patients with indication of
gastric or enteral tubing, it must have been performed at least 2 weeks before the
start of his/her enrollment in the study);
- Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any
pharmacological class;
- Presence of severe comorbidity that, in the investigator's opinion, will put the
patient at a significantly higher risk or will jeopardize protocol compliance;
- Known HIV-positivity;
- 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 (grade > 1 according to Common Terminology
Criteria for Adverse Events [CTCAE] v4.03, of US National Cancer Institute).66;
- Pregnancy or nursing mothers;
- Patients who are willing to become pregnant or are unwilling to use an appropriate
contraceptive method throughout the study period.
- Participation in any clinical trial in the last 12 months, unless there is a
justifiable benefit to the patient to be explained by the principal investigator.