Clinical trial · Interventional
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck
NCT01884259CI-TRIAL-00058741HNO-2completedPhase 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)
This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Hypopharynx Stage III | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Hypopharynx Stage IV | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Larynx Stage III | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Larynx Stage IV | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Oral Cavity Stage III | Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Oral Cavity Stage IV | Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Oropharynx Stage III | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Boost irradiation | Radiation | — | UNRESOLVED |
| Cetuximab Induction | Biological | — | UNRESOLVED |
| Cetuximab Radioimmunotherapy | Biological | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Active comparator is 5-fluorouracil for first three cycles.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: 5-fluorouracil
- Biological: Cetuximab Radioimmunotherapy
- Radiation: Boost irradiation
- type
- EXPERIMENTAL
- label
- B
- description
- All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks). Experimental: cetuximab for the first three cycles.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV * One measureable lesion (CT oder MR) * Age 18 - 75 (including) * Performance Score ECOG 0 - 1 Exclusion Criteria selected: * Distant metastases * ECOG Score \>1 * Prior radiation (Head and neck area) * Creatinin Clearance below 60 ml/µl * Acute infections * Neuropathy grade 3 or 4 * Myocardial Infarction within the last 12 months * Acute coronary syndrome or othe clinically significant cardiovascular diseases
References
Publications (0)
Data not yet available
No reference posted for this study.