Clinical trial · Interventional
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
NCT01301248CI-TRIAL-00004851unknownPhase 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)
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
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 |
|---|---|---|---|
| AJCC Stage III/IV | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiation | Other | — | UNRESOLVED |
| Chemoradiation plus Cetuximab | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy/Cisplatin(GroupA)
- description
- Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)
- interventionNames
- Other: Chemoradiation
- type
- EXPERIMENTAL
- label
- Radiotherapy/Cisplatin/Cetuximab(GroupB)
- description
- Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)
- interventionNames
- Other: Chemoradiation plus Cetuximab
Primary outcomes (1)
- measure
- Determine safety and toxicity of combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed HNSCC of oral cavity, larynx, oropharynx or * hypopharynx; age of 18 years or more * adequate liver (SGOT, SGPT, ALP ≤ 3x normal) * kidneys (creatinine clearance ≥ 60ml/min * heart (no arrythmias, no heart failure) and * bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function * ECOG performance status 0 or 1 and * stage III or IVa to b with measurable lesions * written informed consent Exclusion Criteria: * prior radiotherapy * chemotherapy * concurrent active malignancies * pregnancy * breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.