Actively Recruiting
Cyclin D1 Based TPF (Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage: a Phase II Randomized Controlled Trial
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-11-22
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the predictive value of the protein Cyclin D1 for guiding TPF induction chemotherapy in patients with clinical N2 stage oral squamous cell carcinoma (OSCC). This phase II randomized controlled trial aims to determine if patients with high Cyclin D1 expression benefit from TPF induction chemotherapy compared to surgery and radiotherapy alone. The study addresses ongoing debates about the clinical value of induction chemotherapy in advanced, resectable OSCC and builds on prior research showing subgroup benefits in similar patients. Participants are randomly assigned to one of two groups: the experimental group receives two cycles of TPF induction chemotherapy (docetaxel, cisplatin, and 5-fluorouracil) followed by radical surgery and post-operative radiotherapy, while the control group undergoes surgery and post-operative radiotherapy alone. Chemotherapy is administered intravenously every three weeks with supportive care measures to manage side effects. Surgery involves radical resection and neck dissection with reconstruction, followed by radiotherapy starting 4 to 6 weeks after surgery. Radiotherapy is delivered five days a week for six weeks at specified doses, with additional chemotherapy recommended for high-risk features. Participants undergo baseline tumor assessment and clinical evaluations before surgery, with tumor response measured by clinical and imaging criteria. Toxic effects are monitored weekly during chemotherapy and radiotherapy. Follow-up includes regular monitoring every three months for two years, then every six months for two more years, and annually thereafter. The primary outcome is overall survival at two years, with secondary outcomes including disease-free survival, local recurrence-free survival, and distant metastasis-free survival. The total participation duration covers recruitment, treatment, and follow-up periods with ongoing safety and efficacy assessments.
CONDITIONS
Brief Title
Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Both males and females
- Karnofsky performance status greater than 60
- Histological biopsy confirming squamous cell carcinoma of the oral cavity
- High expression of Cyclin D1 protein
- Clinical stage III or IVA with N2 lymph node involvement and resectable lesions
- Adequate blood cell counts: white blood cells above 3,000/mm3, hemoglobin above 8 g/L, platelets above 80,000/mm3
- Liver function within 2.5 times normal limits for certain enzymes and bilirubin below 1.5 times normal
- Kidney function with serum creatinine below 1.5 times normal
- Able to provide written informed consent
You will not qualify if you...
- Presence of distant metastases or other cancers
- Previous surgery on primary tumors or lymph nodes except biopsy
- Prior radiotherapy or chemotherapy treatments
- Other malignancies within the past 5 years
- Severe lung or heart diseases preventing treatment tolerance
- Legal incapacity or limited legal capacity
- Creatinine clearance below 30 ml/min
- Pregnancy or breastfeeding confirmed by tests
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks (2 cycles every 3 weeks)
Participants in the experimental group receive TPF induction chemotherapy consisting of docetaxel, cisplatin, and 5-fluorouracil administered over 2 cycles to reduce tumor burden before surgery.
Weekly visits during chemotherapy cycles
Duration - Surgery performed at least 2 weeks after chemotherapy; radiotherapy starts 4 to 6 weeks after surgery and lasts about 6 weeks
Participants undergo radical surgery to remove the primary tumor and perform neck dissection, followed by post-operative radiotherapy to eliminate remaining cancer cells.
1 surgery visit and 30 radiotherapy visits (5 days/week for 6 weeks)
Duration - Up to 4 years post-treatment
Participants are monitored regularly to assess overall survival, disease control, and any recurrence or metastasis of cancer.
Visits every 3 months for 2 years, then every 6 months for 2 years
Trial Site Locations
Total: 1 location
1
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
L
Lai-pimg Zhong, PHD
Y
Ying Liu, MPhil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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