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

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Nov 8, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with oral squamous cell carcinoma (a type of mouth cancer) who are at a specific stage of the disease (known as clinical N2). The goal is to see if a certain protein called Cyclin D1 can help predict how well patients will respond to a specific chemotherapy regimen called TPF. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with this type of cancer and have a high level of Cyclin D1 in their tumor.

To be eligible, patients should be in good overall health, meaning they can perform daily activities without much difficulty, and their cancer should be at a stage where it can still be surgically removed. If someone joins the trial, they will receive the TPF chemotherapy treatment and be monitored closely for its effects. It's important for potential participants to understand that this trial is not for everyone; those with certain health conditions, previous cancer treatments, or who are pregnant will not be able to participate. If you or a loved one is considering this trial, it’s a great opportunity to contribute to research that could improve treatment for mouth cancer.

Gender

ALL

Eligibility criteria

• 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.