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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


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Stage III Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival rate

Outcome Description:

To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

Principal Investigator

Zhi-yuan Zhang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Authority:

China: Ethics Committee

Study ID:

TPF for resectable OSCC

NCT ID:

NCT01542931

Start Date:

January 2008

Completion Date:

December 2015

Related Keywords:

  • Stage III Oral Cavity Squamous Cell Carcinoma
  • Stage IVA Oral Cavity Squamous Cell Carcinoma
  • Oral squamous cell carcinoma
  • Induction chemotherapy
  • Surgery
  • Radiotherapy
  • Carcinoma
  • Carcinoma, Squamous Cell

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