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

Stage IVA Oral Cavity Squamous Cell Carcinoma Clinical Trial

Official title:

Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542931
• Other study ID #: TPF for resectable OSCC
• Secondary ID: 2007BAI18B03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2012
• Last updated: August 16, 2017
• Start date: January 2008
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 31, 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-HCG) or lactation period

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Stage III Oral Cavity Squamous Cell Carcinoma
• Stage IVA Oral Cavity Squamous Cell Carcinoma

Intervention

Drug:
• TPF induction chemotherapy
Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.

Locations

Country	Name	City	State
China	Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.	Up to 5 years
Secondary	local control	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	Up to 5 yeas
Secondary	Number of participants with adverse events	All adverse events, including serious adverse events, exposure of all study drugs and radiation.	Up to 5 years