Clinical trial · Interventional
Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers
NCT01233843CI-TRIAL-000366342007/02completedPhase 3ClinicalTrials.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 demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
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 |
|---|---|---|---|
| Squamous Cell Head and Neck Carcinoma | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 fluorouracil | Drug | Fluorouracil | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Drug and radiation
- description
- Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7.
- interventionNames
- Drug: carboplatin
- Drug: 5 fluorouracil
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- drug and radiation
- description
- Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43. This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration).
- interventionNames
- Drug: carboplatin
- Drug: 5 fluorouracil
- Radiation: radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * head and neck locally advanced,non metastatic carcinoma * not suitable for surgery Exclusion Criteria: * non squamous cell head and neck cancer * previous malignancy * previous treatment
References
Publications (0)
Data not yet available
No reference posted for this study.