TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma
This study is currently recruiting participants.
Verified February 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
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
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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
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, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Docetaxel Cisplatin Fluorouracil Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013