A Phase II Trial of TPF Induction Chemotherapy in cN2 OSCC Patients

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared to the standard treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Cisplatin; Docetaxel

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).

• 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