Clinical trial · Interventional
Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change company strategy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation therapy, cisplatin and nimotuzumab
- description
- Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months. Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)
- interventionNames
- Drug: Nimotuzumab
- type
- ACTIVE_COMPARATOR
- label
- Radiation therapy and cisplatin
- description
- Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)
- interventionNames
- Radiation: Radiation Therapy
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available