Status:
RECRUITING
Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage
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 To confirm the predictive value of CCND1 for TPF induction in cN2 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).
- 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
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 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02290145
Start Date
December 1 2016
End Date
December 1 2026
Last Update
November 22 2023
Active Locations (1)
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1
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011