Clinical trial · Interventional
Concurrent Chemoradiotherapy (CCRT) With Paclitaxel Plus Cisplatin in LA Non-small-cell Lung Cancer (NSCLC)
Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer
NCT00686322CI-TRIAL-00005492completedPhase 4ClinicalTrials.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)
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
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 |
|---|---|---|---|
| Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
- interventionNames
- Drug: Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)
Primary outcomes (1)
- measure
- To determine the efficacy of this treatment modality in patients with inoperable stage III NSCLC
- timeFrame
- one year
Secondary outcomes (1)
- measure
- To determine the toxicity profiles of this treatment modality in patients with inoperable stage III NSCLC
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC. * No prior chemotherapy, immunotherapy, or radiotherapy. * Performance status of 0 to 2 on the Zubrod scale. * Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray. * Estimated life expectancy of at least 12 weeks. * Patient compliance and geographic proximity that allow adequate follow-up. * Adequate bone marrow reserve: white blood cell (WBC) count \*4,000/mm3, platelets \>100,000/mm3, and hemoglobin \*10 g/dL. * Informed consent from patient. * Males or females 18 years of age or older. * If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device \[IUD\], birth control pills, or barrier device) during and for three months after trial. Exclusion Criteria: * Active infection (at the discretion of the investigator). * Inadequate liver function (total bilirubin \>1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT and AST may be elevated to 5 times normal in patients with known metastatic disease in the liver). * Inadequate renal function (creatinine \>2.0 mg/dL). * Pregnancy or not using appropriate birth control during the study. * Breast feeding. * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). * Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) * Use of any investigational agent in the month before enrollment into the study. * Patients with leukemia and/or a secondary primary carcinoma except for patients who have had curative therapy to basal cell carcinoma. * Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as previously noted for radiation. * Active cardiac disease requiring therapy for failure, angina, and/or arrhythmias; infarctions within the preceding six months (exception: any patient whose cardiac failure is compensated on medications).
References
Publications (0)
Data not yet available
No reference posted for this study.