Nimotuzumab- Head and neck cancer

Using the monoclonal antibody Nimotuzumab in treating patients with squamous cell carcinoma of head and neck in advanced stages.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000089

Enrollment

Unknown

Registered

2009-10-22

Start date

2009-01-06

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of head and neck in advanced stages.

Interventions

Treatment schemes: 1.Schedule A:Nimotuzumab + RT 2.Schedule B:Nimotuzumab + RT + CT,concurrent 3.Schedule C:Nimotuzumab + RT + CT,sequential 4.Scheme D:Monotherapy with Nimotuzumab 5.Scheme E: Nimotuz

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age greater than or equal to 18 years. 2.Life expectancy of at least 12 weeks. 3.General status ECOG 0-2. 4.Patients give their consent to participate in the study in writing.

Exclusion criteria

Exclusion criteria: 1.Patient at the time of inclusion is receiving another investigational drug. 2.Pregnancy,postpartum or breastfeeding. 3.History of hypersensitivity to any of the components of the pharmaceutical formulation of Nimotuzumab. 4.Presence of a second primary tumor, except basal or squamous cell carcinoma of the skin and neck carcinoma in situ treated.

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events (AE) relating to the administration of Nimotuzumab (AE with causal relationship probable or very likely). Measuring time: every three months until to complete 2 years of treatment.	—

Secondary

Measure	Time frame
Clinical Response (Objective response and Antitumor Clinical Response). Measuring Time: every 3 months until to complete 2 years of treatment. - Objective response (Measurable disease and No measurable disease) - Measurable disease (Complete Response,Partial Response,No change,Progression), - No measurable disease (Complete Response, Partial Response, Stabilization, Progression) - Antitumor Clinical Response(Complete Response, Partial Response, Progressive Disease, Stable disease) Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 2 years of treatment or progression date or death date. Global Survival. Time in months from the inclusion date until death or last date you have news. Measurement time: 2 years of treatment or death. Quality of Life (Quality of Life Questionnaire EORTC QLQ-C30 (version 3) and QLQ-H&N35 (version 3) ). Measuring Time: every 3 months until to complete 2 years of treatment. Adverse events (AE). Measuring Time: 2 years of treatment. - Type of AE (name of the adverse event) - Time between the time of administration and the occurrence of AE (hours and minutes or days) - Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) - Serious AE (Severe/Serious, not serious/not serious) - Intensity of AE (Grade 1:Slight, Grade 2:Moderate, Grade 3:Severe, Grade 4:Danger to life, Grade 5:Death) - Causal relationship (Remote, possible, probable, very likely) accordint to FDA criteria - Possible causal treatment (name of treatment that provo, if one considers that the AE is due to the administration Nimotuzumab or the QT and/or RT or other concomitant treatment) - Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) - Result of AE (recovered, improved, persist, sequelae)	—

Measure

Time frame

Clinical Response (Objective response and Antitumor Clinical Response). Measuring Time: every 3 months until to complete 2 years of treatment. - Objective response (Measurable disease and No measurable disease) - Measurable disease (Complete Response,Partial Response,No change,Progression), - No measurable disease (Complete Response, Partial Response, Stabilization, Progression) - Antitumor Clinical Response(Complete Response, Partial Response, Progressive Disease, Stable disease) Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 2 years of treatment or progression date or death date. Global Survival. Time in months from the inclusion date until death or last date you have news. Measurement time: 2 years of treatment or death. Quality of Life (Quality of Life Questionnaire EORTC QLQ-C30 (version 3) and QLQ-H&N35 (version 3) ). Measuring Time: every 3 months until to complete 2 years of treatment. Adverse events (AE). Measuring Time: 2 years of treatment. - Type of AE (name of the adverse event) - Time between the time of administration and the occurrence of AE (hours and minutes or days) - Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) - Serious AE (Severe/Serious, not serious/not serious) - Intensity of AE (Grade 1:Slight, Grade 2:Moderate, Grade 3:Severe, Grade 4:Danger to life, Grade 5:Death) - Causal relationship (Remote, possible, probable, very likely) accordint to FDA criteria - Possible causal treatment (name of treatment that provo, if one considers that the AE is due to the administration Nimotuzumab or the QT and/or RT or other concomitant treatment) - Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) - Result of AE (recovered, improved, persist, sequelae)

—

Countries

Cuba

Contacts

Public ContactPatricia MD. Piedra

CIMAB SA.

patrip@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026