Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Carboplatin

Mitogens

Tubulin Modulators

Antimitotic Agents

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.

NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.

Radiation therapy

All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Surgical resection

Heather A. Wakelee

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.

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)

This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.

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.

The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.

Aventis Pharmaceuticals

Stanford University

Assistant Professor of Medicine

Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720

Docetaxel / Carboplatin / XRT + Surgical Resection

Group 1

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Accrual was very slow. The study was halted with accrual of only 13 patients. These results were published.

Dr. Heather Wakelee

All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.

Results were published PMID 21774104

All enrolled patients were analyzed in the published manuscript

Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival

This planned analysis of gene expression patterns was not performed.

Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.

Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen

2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.

Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.

Docetaxel+Carboplatin +Radiation+Surgery

All patients alive and not censored at 2 years

2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.

Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.

Spots Global Cancer Trial Database for Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

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