Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT03326947

Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-02-20

60

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Phage II Trial of Stathmin as Predictive Biomarker for TPF Induction Chemotherapy in OSCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological diagnosis of squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
  • Age between 18 and 75 years old
  • Male or female
  • Karnofsky performance status greater than 70
  • Low stathmin 1 expression by immunohistochemistry
  • Clinical stage III or IVA
  • White blood cell count greater than 3,000/mm3
  • Hemoglobin level greater than 8 g/L
  • Platelet count greater than 80,000/mm3
  • Alanine aminotransferase and aspartate transaminase less than 2.5 times the upper limit of normal
  • Bilirubin less than 1.5 times the upper limit of normal
  • Serum creatinine less than 1.5 times the upper limit of normal
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Presence of distant metastatic disease or other cancers
  • Previous surgery on the primary tumors or lymph nodes (except diagnostic biopsy)
  • Previous radiotherapy or chemotherapy
  • Other malignancies within the last 5 years
  • Severe pulmonary or cardiac diseases
  • Legal incapacity or limited legal capacity
  • Creatinine clearance less than 30 ml/min
  • Pregnancy or lactation confirmed by serum or urine β-HCG

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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