Clinical trial · Interventional
Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
Phase II Study of Nimotuzumab (TheraCim-hR3) Concurrent With Cisplatin/Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00702481CI-TRIAL-00064303completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to define the response and toxicities with the addition of Nimotuzumab to chemoradiation for head and neck cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab/CDDP/RT
- description
- Open label treatment arm of Nimotuzumab and cisplatin and radiation
- interventionNames
- Drug: Nimotuzumab
- Drug: Cisplatin
- Radiation: Radiation
Primary outcomes (1)
- measure
- To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT).
- timeFrame
- 16 weeks
Secondary outcomes (1)
- measure
- To assess the toxicities associated with this regimen
- timeFrame
- 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck. * Locally advanced disease, unresectable disease or resectable disease where organ-preservation is intended * Age \> 18 years * Adequate performance status of ECOG 0-2 * Life expectancy of at least 3 months * Written informed consent to participate in the study * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. * Patients must have normal organ and marrow function as defined below: * leukocytes \>3,000/uL * absolute neutrophil count \>1,500/uL * platelets \>100,000/uL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) \< 2.5X normal . Creatinine within normal range and CCT(Cockcroft-Gault) \> 50 ml/min Exclusion Criteria: * Prior treatment with anti-EGFR or chemotherapy/radiotherapy * Evidence of CNS metastases * Poor performance status (ECOG 3-4) * Evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, nephritic syndrome, uncontrolled metabolic disorders such as diabetes mellitus, uncontrolled hypertension or uncontrolled significant infections) * Pregnancy or breast-feeding (women of child-bearing potential) * Prior severe allergic drug reactions * Prior history of cancer in the last 5 years prior to enrollment, other than curatively treated cancer of the cervix or non-melanoma skin cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.