Clinical trial · Interventional
Phase I Cetuximab and Concurrent Radio-chemotherapy
Determination of the Toxicity of Standard Dose Cetuximab Together With Concurrent Individualised, Isotoxic Accelerated Radiotherapy and Cisplatin-vinorelbine for Patients With Stage III Non-small Cell Lung Cancer: A Phase I Study
NCT00522886CI-TRIAL-00005227completedPhase 1ClinicalTrials.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 determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) 3 months after the ende of chemo-radiation
- timeFrame
- 3 months
Secondary outcomes (1)
- measure
- During and after chemo-radiation: (CTC 3.0) Dysphagia, Cough, Dyspnea, Skin rash, Myelitis, Neuropathy, Neutrophiles, Platelets, Hemoglobin, Diarrhea, Renal failure, Liver dysfunction, Tumour response 3 m. after end chemo-radiation and Survival
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer * Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion) * WHO performance status 0 or 1 * Less than 10% weight loss in the last 6 months * Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value * No recent severe cardiac disease * Adequate bone marrow function * Adequate renal function * Adequate hepatic function * Life expectancy more than 6 months * Measurable cancer * Willing and able to comply with study prescriptions * 18 years or older * Not pregnant or breast feeding * Written informed consent * No previous radiotherapy to the chest Exclusion Criteria: * Not non-small cell lung cancer histology * Mixed pathology * History of prior chest radiotherapy * Recent (\<3 months) myocardial infarction * Uncontrolled infectious disease * Less than 18 years old * Inadequate pulmonary function * Other active malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.