TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT01542931|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage III Oral Cavity Squamous Cell Carcinoma Stage IVA Oral Cavity Squamous Cell Carcinoma||Drug: TPF induction chemotherapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2008|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 31, 2015|
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.
- Survival rate [ Time Frame: Up to 5 years ]To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.
- local control [ Time Frame: Up to 5 yeas ]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 ]All adverse events, including serious adverse events, exposure of all study drugs and radiation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542931
|Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University|
|Shanghai, Shanghai, China, 200011|
|Study Chair:||Zhi-yuan Zhang, MD, PhD||Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University|