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

Recruiting now · Phase 2

Conditions studied: Mouth Neoplasms, Carcinoma, Squamous Cell

In brief

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

Key facts

Study ID

NCT02290145

Run by

Shanghai Jiao Tong University School of Medicine

People needed

48

Starts

2016-12-01

Expected to finish

2026-12-01

Last updated by the study team

2023-11-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Cyclin D1 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

You may not qualify if…

• 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.

Where it is running

• Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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