Clinical trial · Interventional
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
NCT00622349CI-TRIAL-00009196completedPhase 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 determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin, docetaxel | Drug | — | UNRESOLVED |
| Cisplatin, Ifosfamide, Gemcitabine | Drug | — | UNRESOLVED |
| Ifosfamide, Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Cisplatin, Ifosfamide, Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Ifosfamide, Gemcitabine
- type
- EXPERIMENTAL
- label
- C
- interventionNames
- Drug: Cisplatin, docetaxel
Primary outcomes (1)
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of non-small cell lung cancer * Advanced (unresectable or functionally inoperable) stage III or stage IV disease * Availability for participating in the detailed follow-up of the protocol * Presence of an evaluable or measurable lesion * Informed consent Exclusion Criteria: * Prior treatment with chemotherapy * Operable patient with resectable tumour * Performance status \< 60 on the Karnofsky scale * A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) * Polynuclear cells \< 2,000/mm³ * Platelet cells \< 100,000/mm³ * Serum bilirubin \>1.5 mg/100 ml * Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min * Perception hypoacousia * Peripheral neuropathy * Recent myocardial infarction (less than 3 months prior to date of diagnosis) * Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia * Uncontrolled infectious disease * Serious medical or psychological factors which may prevent adherence to the treatment schedule
References
Publications (0)
Data not yet available
No reference posted for this study.