Clinical trial NCT01542931: TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stage III Oral Cavity Squamous Cell Carcinoma
Stage IVA Oral Cavity Squamous Cell Carcinoma
Keywords: Oral squamous cell carcinoma
Induction chemotherapy
Surgery
Radiotherapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: local control
timeFrame: Up to 5 yeas
measure: Number of participants with adverse events
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
name: Zhi-yuan Zhang, MD, PhD
role: STUDY_CHAIR
References:
citation: Ju WT, Liu Y, Wang LZ, Li J, Ren GX, Sun J, Tu WY, Hu YJ, Ji T, Yang WJ, Li J, He Y, Wang YA, Zhang CP, Zhong LP, Zhang ZY. Phase III trial of docetaxel cisplatin 5-fluorouracil induction chemotherapy for resectable oral cancer suggests favorable pathological response as a surrogate endpoint for good therapeutic outcome. Cancer Commun (Lond). 2021 Mar;41(3):279-283. doi: 10.1002/cac2.12136. Epub 2021 Jan 20. No abstract available.
citation: Hu YJ, Sun WW, Zhao TC, Liu Y, Zhu DW, Wang LZ, Li J, Zhang CP, Zhang ZY, Zhong LP. Cyclin D1 overexpression enhances chemosensitivity to TPF chemotherapeutic agents via the caspase-3 pathway in oral cancer. Oncol Lett. 2020 Nov;20(5):154. doi: 10.3892/ol.2020.12015. Epub 2020 Aug 24.
citation: Yang CZ, Ma J, Zhu DW, Liu Y, Montgomery B, Wang LZ, Li J, Zhang ZY, Zhang CP, Zhong LP. GDF15 is a potential predictive biomarker for TPF induction chemotherapy and promotes tumorigenesis and progression in oral squamous cell carcinoma. Ann Oncol. 2014 Jun;25(6):1215-22. doi: 10.1093/annonc/mdu120. Epub 2014 Mar 24.
citation: Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. doi: 10.1200/JCO.2012.43.8820. Epub 2012 Nov 5.