Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
To investigate the predictive value of stathmin expression as a predictive biomarker in OSCC patients, who treated with TPF (docetaxel, cisplatin and 5-fluorouracil ) induction chemotherapy followed by radical surgery and radiotherapy/chemoradiotherapy.
Official title: A Randomized Phase II Trial of Low Stathmin Expression as a Predictive Biomarker for OSCC Patients Receiving TPF Induction Chemotherapy Followed by Radical Surgery and Radiotherapy/Chemoradiotherapy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2018-01-01
Completion Date
2027-01-01
Last Updated
2024-02-20
Healthy Volunteers
No
Conditions
Interventions
docetaxel, cisplatin and 5-fluorouracil
Drug: TPF induction chemotherapy TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m\^2), cisplatin(75 mg/m\^2), 5-Fu(750 mg/m\^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery. Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy, for high risk factors, concurrent chemotherapy with cisplatin of 80mg/m2. Other Names: TPF protocol group Procedure/Surgery: surgery In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed. Radiation: radiotherapy
Locations (1)
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China