Clinical trial · Interventional
Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT00238615CI-TRIAL-00017878terminatedPhase 2Results postedClinicalTrials.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): low accrual
Summary
Brief summary (as posted)
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
Conditions
Conditions (2)
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 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Radiation therapy | Procedure | — | UNRESOLVED |
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy+Radiation+Surgery
- description
- 1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
- Procedure: Radiation therapy
- Procedure: Surgical resection
Primary outcomes (1)
- measure
- 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
- timeFrame
- Two years
- description
- Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed stage IIIA or IIIB NSCLC * Patients must have measurable disease * No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC. * Age\>18 years * Life expectancy \>12 months * ECOG performance status 0-1 * Normal organ and marrow function * Medically fit for surgery at time of enrollment. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment. * Ability to understand and willingness to sign the consent form. Exclusion Criteria: * Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC. * Patients receiving any other investigational agents. * Known metastatic disease (brain or any other site) * History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study. * Peripheral neuropathy \>grade 1 * Uncontrolled concurrent illness * Pregnant women * Weight loss\>10% in the past 3 months before diagnosis. * Hyperglycemia - exclusion from PET analysis * HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
References
Publications (2)
- RESULTKozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db. PMID 21774104
- RESULTDas M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14. PMID 21752720