Not provided
Not provided
Not provided
Not provided
Not provided
funding was withdrawn from Drug company
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily Radiation. This will be followed by more hi-dose chemotherapy. We anticipate this regimen to target early distant microscopic spread by using one cycle of chemotherapy prior to radiation, and to achieve control of the disease in the lung by combining pulsed low-dose sensitizing Abraxane, with radiation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | 1) PTV = CTV (GTV + 1.5-cm margins and the most adjacent nodal regions) + 0.5 cm margins to 5,040 cGy in 180 cGy daily fractions; and (2) Cone Down PTV = GTV +1.5 cm margins to 6,480 cGy. | ||
| Paclitaxel Protein-Bound, and CARBOPLATIN | Drug | Induction Chemotherapy Abraxane(260 mg/m2) / Carboplatin (AUC of 6) x one cycle Concurrent Chemotherapy(with radiation)--for first 3 pts--20 mg/m2 Abraxane, 3 times per week then for next group of 3 pts--30 mg/m2 Abraxane twice a week |
| Measure | Description | Time Frame |
|---|---|---|
| To assess feasibility of one cycle induction chemotherapy of Abraxane plus Carboplatin followed by low-dose sensitizing Abraxane and radiation followed by consolidation Abraxane and carboplatin for stage III NSCLC. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the local tumor response rate | 4 years | |
| To estimate 2-year in-field tumor control. | 6 year | |
| To estimate 2-year disease free survival (DFS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuhchyau Chen, MD,PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester, Medical Center | Rochester | New York | 14642 | United States |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013660 | Taxes |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 years |
| To estimate 2-year overall survival (OS). | 6 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |