Chemotherapy for advanced oral cancer patients with high cyclin D1 expression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of TPF induction chemotherapy in patients with oral squamous cell carcinoma (OSCC) who have high cyclin D1 expression and are at clinical N2 stage. The study aims to determine if this chemotherapy approach can improve outcomes such as overall survival and disease-free survival compared to standard treatments. Participants will receive TPF chemotherapy followed by surgery and possibly post-operative radiotherapy. The trial is designed as a prospective, open-label, randomized control trial to assess the benefits specifically for the targeted patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lai-pimg Zhong, PHD
• Email: zhonglaiping@163.com
• Phone: +86 021-23271699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.