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| ID | Type | Description | Link |
|---|---|---|---|
| 2007BAI18B03 | Other Grant/Funding Number | National Key Technology R&D Program of China/2007BAI18B03 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery and radiotherapy | No Intervention | Surgery and post-operative radiotherapy. | |
| TPF induction chemotherapy | Experimental | Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPF induction chemotherapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-yuan Zhang, MD, PhD | Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33471949 | Derived | 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. | |
| 32934722 |
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All adverse events, including serious adverse events, exposure of all study drugs and radiation.
| Up to 5 years |
| Derived |
| 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. |
| 24669014 | Derived | 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. |
| 23129742 | Derived | 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. |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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