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TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542931
First Posted: March 2, 2012
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
  Purpose
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.

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Survival rate [ Time Frame: Up to 5 years ]
    To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.


Secondary Outcome Measures:
  • 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.


Enrollment: 256
Study Start Date: January 2008
Study Completion Date: December 31, 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
China, Shanghai
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: Zhi-yuan Zhang, MD, PhD Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lai-ping Zhong, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01542931     History of Changes
Other Study ID Numbers: TPF for resectable OSCC
2007BAI18B03 ( Other Grant/Funding Number: National Key Technology R&D Program of China/2007BAI18B03 )
First Submitted: February 26, 2012
First Posted: March 2, 2012
Last Update Posted: August 21, 2017
Last Verified: February 2012

Keywords provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
Oral squamous cell carcinoma
Induction chemotherapy
Surgery
Radiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs