drugset / Trial / NCT01587820
Intra-arterial Versus Intravenous Cisplatin, Combined With Radiation, for Oral Cavity and Oropharynx Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label investigator initiated pilot/ feasibility study comparing the effectiveness of intra-arterial administration of cisplatin therapy to intravenous administration of cisplatin when each is combined with the radiation therapy found in standard care. Participants will be randomized to either intra-arterial or intravenous cisplatin chemotherapy. This study is designed to determine whether a large scale study is practical in the investigators clinical setting. Approximately 10 subjects will be enrolled over a 2 year period.
Timeline
- Start
- 2012-06
- Primary completion
- 2014-08
- Completion
- 2014-08
Publications
- Background Samant S, van den Brekel MW, Kies MS, Wan J, Robbins KT, Rosenthal DI, Rasch C, Weber RS. Concurrent chemoradiation for adenoid cystic carcinoma of the head and neck. Head Neck. 2012 Sep;34(9):1263-8. doi: 10.1002/hed.21905. Epub 2011 Nov 15.
- Background Robbins KT, Howell SB, Williams JS. Intra-arterial chemotherapy for head and neck cancer: is there a verdict? Cancer. 2010 May 1;116(9):2068-70. doi: 10.1002/cncr.24930. No abstract available.
- Background Robbins KT, Homma A. Intra-arterial chemotherapy for head and neck cancer: experiences from three continents. Surg Oncol Clin N Am. 2008 Oct;17(4):919-33, xi. doi: 10.1016/j.soc.2008.04.015.
- Background Doweck I, Robbins KT, Samant S, Vieira F. Intra-arterial chemoradiation for T3-4 oral cavity cancer: treatment outcomes in comparison to oropharyngeal and hypopharyngeal carcinoma. World J Surg Oncol. 2008 Jan 14;6:2. doi: 10.1186/1477-7819-6-2.
- Background Rabbani A, Hinerman RW, Schmalfuss IM, Amdur RJ, Morris CG, Peters KR, Robbins KT, Mendenhall WM. Radiotherapy and concomitant intraarterial cisplatin (RADPLAT) for advanced squamous cell carcinomas of the head and neck. Am J Clin Oncol. 2007 Jun;30(3):283-6. doi: 10.1097/01.coc.0000258118.38177.74.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | Other |
| Subject | Cisplatin | Other / unclassified | 150 mg/m2 | Other |