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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery and radiotherapy

Surgery and post-operative radiotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

TPF induction chemotherapy

Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.

Group Type EXPERIMENTAL

TPF induction chemotherapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Followed by surgery and radiotherapy.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No