Pemetrexed/Carboplatin vs Vinorelbine/Carboplatin in Patients With Completely Resected Non-small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT01258127|
Recruitment Status : Unknown
Verified December 2010 by Shanghai Nancy Medical Sci-Tech Co. Ltd.
Recruitment status was: Recruiting
First Posted : December 10, 2010
Last Update Posted : December 10, 2010
|Condition or disease|
|Non-small Cell Lung Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||134 participants|
|Official Title:||Adjuvant Chemotherapy of Pemetrexed/Carboplatin Compared With Vinorelbine/Carboplatin in Patients With Completely Resected NSCLC|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2015|
Pemetrexed and Carboplatin
For patients in arm pemetrexed/carboplatin, folic acid (350-1000 μg) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. Vitamin B12 (1000 μg) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy. Dexamethasone (4 mg of oral or equivalent) given twice daily should be taken on the day before, the day of, and the day after each dose of pemetrexed, for rash prophylaxis unless medically contraindicated. Patients must receive pemetrexed at day 1 at the dose of 500 mg/m2 as an IV infusion over approximately 10 minutes, then carboplatin target area under the concentration curve (AUC) 6 (i.v. infusion over 30 minutes) on day 1 of a 21-day cycle. A total of four cycles is intended.
Vinorelbine and Carboplatin
Patients in arm vinorelbine and carboplatin follow the regimen: The scheduled infusion time is 6-10 minutes for IV vinorelbine at the dose of 25 mg/m2 d1,8, then carboplatin target area under the concentration curve (AUC) 6 (i.v. infusion over 30 minutes) on day 1 of a 21-day cycle. A total of four cycles is intended.
- To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin [ Time Frame: 1 month ]To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin in patients with NSCLC stage IB, IIA, IIB and T3N1 (without need for further radiotherapy). Treatment is considered to have clinical feasibility if dose limiting toxicity (DLT) will not be observed, and no non-acceptance by the patient leading to premature withdrawal, and no death due to cancer or cancer therapy will occur.
- To determine and compare the drug delivery between both treatment arms [ Time Frame: 1 month ]
- The relapse free survival [ Time Frame: 3 months ]
- The overall survival [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258127
|Contact: Qiang Li, MDfirstname.lastname@example.org|
|Cancer Hospital of Sichuan Province||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Qiang Li, MD +86-28-88867774 email@example.com|