Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC
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|ClinicalTrials.gov Identifier: NCT03326947|
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Neck||Drug: docetaxel, cisplatin and 5-fluorouracil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: TPF group
The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed with surgery and radiotherapy/chemoradiotherapy.
docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day
Drug: 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.
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.
No Intervention: Control group
The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.
- Overall survival [ Time Frame: 12 weeks. ]Overall survival was calculated from the date of randomization to death from any cause
- Disease free survival [ Time Frame: 12 weeks. ]Disease free survival was calculated from the date of randomization to recurrence, locoregional recurrence, or death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326947
|Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Lai-ping Zhong, MD, PhD +86-21-23271699 ext 5160 firstname.lastname@example.org|
|Principal Investigator: Lai-ping Zhong, MD, PhD|