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GDF15 Based TPF Induction Chemotherapy for OSCC Patients

NCT02285530 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-04-05

No results posted yet for this study

Summary

The purpose of this study is to confirm the predictive value of GDF15 expression for TPF induction in T3/T4cN0M0 patients with OSCC

Conditions

  • Mouth Neoplasms
  • Carcinoma, Squamous Cell

Interventions

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.

PROCEDURE

surgery group

Radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285530 on ClinicalTrials.gov