Clinical trial · Interventional
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
NCT00582634CI-TRIAL-00041782completedPhase 2ClinicalTrials.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 if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer * To evaluate the time to progression and overall survival * To evaluate toxicities of this chemotherapy combination in the adjuvant setting * To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen
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 |
|---|---|---|---|
| docetaxel and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel followed by cisplatin
- description
- Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles.
- interventionNames
- Drug: docetaxel and cisplatin
Primary outcomes (3)
- measure
- Time to progression
- timeFrame
- 36 months
- measure
- Overall survival
- timeFrame
- 36 months
- measure
- Incidence of adverse events
- timeFrame
- Baseline to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study * Performance Status ECOG 0 or 1 * Peripheral neuropathy: \< grade 1 * Adequate blood cell counts * Adequate liver and hepatic function * Women of childbearing potential must have a negative pregnancy test. * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter Exclusion Criteria: * Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80. * Women who are breast-feeding. * Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively) * Uncontrolled cardiac disease or uncontrolled hypertension
References
Publications (0)
Data not yet available
No reference posted for this study.