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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01542931
First received: February 26, 2012
Last updated: March 1, 2012
Last verified: February 2012
  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: 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 Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 256
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)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542931

Contacts
Contact: Zhi-yuan Zhang +86-21-23271699 ext 5385 zhang.z.y@hotmail.com
Contact: Lai-ping Zhong +86-21-23271699 ext 5160 zhonglaiping@163.com

Locations
China, Shanghai
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    zhonglaiping@163.com   
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

No publications provided by Shanghai Jiao Tong University School of Medicine

Additional 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
Study First Received: February 26, 2012
Last Updated: March 1, 2012
Health Authority: China: Ethics Committee
China: Ministry of Science and Technology

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Oral squamous cell carcinoma
Induction chemotherapy
Surgery
Radiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014