Clinical trial · Interventional
Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.
NCT00633568CI-TRIAL-00016860terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel | Drug | — | UNRESOLVED |
| Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
- interventionNames
- Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
- type
- EXPERIMENTAL
- label
- B
- description
- Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
- interventionNames
- Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Primary outcomes (1)
- measure
- Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of non-small cell carcinoma of the lung * Initially unresectable non-metastatic stage III disease * Availability for participating in the detailed follow-up of the protocol * Presence of an evaluable or measurable lesion * Written informed consent * No functional or anatomical contraindication to chest irradiation Exclusion Criteria: * Prior treatment with chemotherapy, radiotherapy or surgery * Performance status \< 60 on the Karnofsky scale * History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval) * Neutrophils \< 2,000/mm³ * Platelet cells \< 100,000/mm3 * Serum bilirubin \> 1.5 mg/100 ml * Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value * Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min * Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris * Congestive cardiac failure or cardiac arrhythmia requiring medical treatment * Uncontrolled infectious disease * Symptomatic polyneuropathy * Auditive impairment contra-indicating cisplatin administration * Serious medical or psychological factors which may prevent adherence to the treatment schedule * Malignant pleural or pericardial effusion * Homolateral supraclavicular lymph node excepting upper lobe lesion * Heterolateral supraclavicular lymph node * Known hypersensitivity to docetaxel or cisplatin * Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
References
Publications (0)
Data not yet available
No reference posted for this study.