TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Phase 2

Completed

• Conditions: Stage III Oral Cavity Squamous Cell Carcinoma; Stage IVA Oral Cavity Squamous Cell Carcinoma
• Interventions: Drug: TPF induction chemotherapy

• Registration Number: NCT01542931
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

Detailed Description

The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is locoregional control rates (1, 2 years), and the safety.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2012-02
• Study First Submitted: 2012-02-26
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Primary Completion: 2015-12
• Study Completion: 2015-12-31
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Written informed consent prior to any study activities
• Age 18-75 years old
• Histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
• Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, UICC 2002), resectable lesions
• Karnofsky performance status (KPS) > 60
• Adequate hematologic function: white blood cell > 3,000/mm^3, hemoglobin > 8g/L, platelet count > 80,000/mm^3
• Hepatic function: ALAT/ASAT < 2.5 times the upper limit of normal (ULN), bilirubin < 1.5 times ULN
• Renal function: serum creatinine < 1.5 x ULN
• Life expectancy ≥ 6 months

Exclusion Criteria

• Evidence of distant metastatic disease and other cancers
• Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
• Previous radiotherapy for the primary tumor or lymph nodes
• Prior chemotherapy or immunotherapy for the primary tumor
• Other previous malignancy within 5 years
• Systematic diseases history of severe pulmonary or cardiac diseases
• Creatinine Clearance < 30 ml/min
• Legal incapacity or limited legal capacity
• Pregnancy (confirmed by serum or urine β-HCG) or lactation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPF induction chemotherapy	TPF induction chemotherapy	Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.

Primary Outcome Measures

Name	Time	Method
Survival rate	Up to 5 years	To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.

Secondary Outcome Measures

Name	Time	Method
local control	Up to 5 yeas	To evaluate the 1, 2, 3, 5-year local and regional control rate and distant metastasis rate after TPF indcution chemotherapy followed by surgery and radiotherapy
Number of participants with adverse events	Up to 5 years	All adverse events, including serious adverse events, exposure of all study drugs and radiation.

Trial Locations

Locations (1)

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China