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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

Phase 2
18 Years
70 Years
Not Enrolling
Carcinoma, Head and Neck Cancer

Thank you

Trial Information

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

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 24 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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Daniel Grabarz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centro Oncológico de Mogi das Cruzes


Brazil: National Committee of Ethics in Research

Study ID:

EF 118



Start Date:

September 2011

Completion Date:

November 2017

Related Keywords:

  • Carcinoma
  • Head and Neck Cancer
  • Carcinoma
  • Head and Neck Neoplasms