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RECRUITING
NCT02290145
PHASE2

Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC

Official title: Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2016-12

Completion Date

2026-12

Last Updated

2023-11-22

Healthy Volunteers

No

Interventions

DRUG

TPF group

The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin:75 mg/m2 5-Fu:750 mg/m2/day

PROCEDURE

surgery group

The patients in the control group received the radical surgery and post-operative radiotherapy.

RADIATION

Post-operative radiotherapy

Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

Locations (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China