TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
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|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|
|Actual Primary Completion Date :||December 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|