Status:
UNKNOWN
GDF15 Based TPF Induction Chemotherapy for OSCC Patients
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Mouth Neoplasms
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to confirm the predictive value of GDF15 expression for TPF induction in T3/T4cN0M0 patients with OSCC
Detailed Description
Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radica...
Eligibility Criteria
Inclusion
- Age: 18 to 75 years old.
- Sex: both males and females.
- Karnofsky performance status (KPS) \>60.
- Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
- GDF1 high expression
- Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[international Union Against Cancer \] 2002) with resectable lesions.
- Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3.
- Hepatic function: ALAT(alanine aminotransferase)/ASAT(aspartate transaminase) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN.
- Renal function: serum creatinine \<1.5 times ULN.
- Written informed consent
Exclusion
- Evidence of distant metastatic disease and other cancers.
- Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
- Previous radiotherapy or chemotherapy.
- Other previous malignancies within 5 years.
- Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
- Legal incapacity or limited legal capacity.
- Creatinine clearance \<30ml/min.
- Pregnancy (confirmed by serum or urine β-HCG) or lactation period.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02285530
Start Date
December 1 2019
End Date
December 31 2025
Last Update
April 5 2023
Active Locations (1)
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1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011