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Recruiting Phase 2

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

NCT02290145 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2016-12
Last updated
2023-11-22

Condition(s) studied

Mouth NeoplasmsCarcinoma, Squamous Cell

Investigational drug(s) / intervention(s)

TPF groupsurgery groupPost-operative radiotherapy

TPF group: The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin:75 mg/m2 5-Fu:750 mg/m2/day

surgery group: The patients in the control group received the radical surgery and post-operative radiotherapy.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • overall survival rate as a measure by the numbers of living patients — 2 year

Trial sites (1)

FacilityCityRegionStatus
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02290145 on ClinicalTrials.gov ↗ ← All trials in China