TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
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.
Stage III Oral Cavity Squamous Cell Carcinoma
Stage IVA Oral Cavity Squamous Cell Carcinoma
Drug: TPF induction chemotherapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Survival rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.
- local control [ Time Frame: Up to 5 yeas ] [ Designated as safety issue: Yes ]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
- Number of participants with adverse events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]All adverse events, including serious adverse events, exposure of all study drugs and radiation.
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: Surgery and radiotherapy
Surgery and post-operative radiotherapy.
Experimental: TPF induction chemotherapy
Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.
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.
Other Name: Followed by surgery and radiotherapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542931
|Contact: Zhi-yuan Zhang||+86-21-23271699 ext firstname.lastname@example.org|
|Contact: Lai-ping Zhong||+86-21-23271699 ext email@example.com|
|Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Lai-ping Zhong, MD, PhD +86-21-23271699 ext 5160 firstname.lastname@example.org|
|Study Chair:||Zhi-yuan Zhang, MD, PhD||Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University|