Clinical trial · Interventional
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
NCT00999700CI-TRIAL-00029408INTERCEPTORunknownPhase 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)
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
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 Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
- interventionNames
- Drug: docetaxel - cisplatin - 5-fluorouracil
- Radiation: radiotherapy
- Drug: cetuximab
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
- interventionNames
- Drug: cisplatin
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years of age * Histologically or cytologically confirmed diagnosis of HNSCC * Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery) * At least one uni-dimensional measurable lesion either by CT scan or MRI * Signed written informed consents prior to beginning protocol Specific procedures: * Tumor tissue available for immunohistochemical staining of EGFR expression and HPV * Life expectancy of \> 3 months at study entry * ECOG Performance Status of \<2 at study entry. * Effective contraception if risk of conception exists. * Neutrophils \> 2.0/mm³, platelet count \> 100,000/mm³, and hemoglobin \> 10 g/dl * Normal liver function * Serum creatinine \> 1.25 x ULN and/or creatinine clearance \> 60 ml/min Exclusion Criteria: * Prior systemic chemotherapy and/or radiotherapy * Known peripheral neuropathy \> grade 2 NCI-CTC version 3.0 * Known chronic heart failure * Prior surgery, excluding prior diagnostic biopsy * Known drug abuse * Active uncontrolled infection * Other concomitant anticancer therapy * Distant metastasis * Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol * Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry * Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent * Nasopharyngeal carcinoma WHO type II or III * Known allergic reaction against any of the components of the treatment * Pregnancy (absence confirmed by beta-HCG test) or lactation period * Any prior or on-going investigational medication * Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
References
Publications (10)
- RESULT- J.P. Pignon et al. Lancet 2000
- RESULT- A. Forastiere et al., New Engl J Med 2001
- RESULT- Adelstein DJ J.Clin.Oncol. 2003
- RESULT- Henke, New England 2004
- RESULT- J.A. Bonner et al., New Engl J Med 2006
- RESULTMerlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146. PMID 16476835
- RESULT- Posner M et al, New Engl J Med 2007
- RESULT- Vermorken J et al, New Engl J Med 2007
- RESULT- Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
- RESULTMerlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7. PMID 12927569