Chemotherapy for advanced oral cancer patients with high cyclin D1 expression
Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial
This study is testing if a specific chemotherapy treatment can help people with advanced oral cancer who have high levels of a protein called cyclin D1 live longer and stay cancer-free after treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT02290145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with high cyclin D1 expression and resectable locally advanced oral squamous cell carcinoma.
Not a fit: Patients with distant metastatic disease, previous cancer treatments, or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and treatment outcomes for patients with advanced oral squamous cell carcinoma.
How similar studies have performed: Previous studies have shown mixed results for induction chemotherapy in similar patient populations, but this specific approach targeting cyclin D1 high expression is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.