drugset / Trial / NCT00261703
Docetaxel in Head and Neck Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: * Phase II: To determine the best treatment scheme (TPF vs. PF). * Phase III: To compare the time to progression and the treatment failure at the 3 arms. Secondary objectives: * To evaluate the safety at the 3 arms. * To compare the progression , overall survival and locoregional control at the 3 arms.
Timeline
- Start
- 2002-12
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
- Hitt R, Iglesias L, Lopez-Pousa A, Berrocal-Jaime A, Grau JJ, Garcia-Giron C, Martinez-Trufero J, Guix M, Lambea-Sorrosal J, Del Barco-Morillo E, Leon-Vintro X, Cunquero-Tomas AJ, Baste N, Ocana A, Cruz-Hernandez JJ; the Spanish Head and Neck Cancer Cooperative Group (TTCC). Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial. Clin Transl Oncol. 2021 Apr;23(4):764-772. doi: 10.1007/s12094-020-02467-8. Epub 2020 Aug 14.
- Hitt R, Grau JJ, Lopez-Pousa A, Berrocal A, Garcia-Giron C, Irigoyen A, Sastre J, Martinez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernandez JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. doi: 10.1093/annonc/mdt461. Epub 2013 Nov 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 750 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | — |