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

Primary Purpose

Stage III Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

TPF induction chemotherapy

About this trial

This is an interventional treatment trial for Stage III Oral Cavity Squamous Cell Carcinoma focused on measuring Oral squamous cell carcinoma, Induction chemotherapy, Surgery, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surgery and radiotherapy

TPF induction chemotherapy

Arm Description

Surgery and post-operative radiotherapy.

Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.

Outcomes

Primary Outcome Measures

Survival rate

To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.

Secondary Outcome Measures

local control

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

All adverse events, including serious adverse events, exposure of all study drugs and radiation.

Full Information

NCT ID

NCT01542931

First Posted

February 26, 2012

Last Updated

August 16, 2017

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01542931

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma

Keywords

Oral squamous cell carcinoma, Induction chemotherapy, Surgery, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery and radiotherapy

Arm Type

No Intervention

Arm Description

Surgery and post-operative radiotherapy.

Arm Title

TPF induction chemotherapy

Arm Type

Experimental

Arm Description

Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.

Intervention Type

Drug

Intervention Name(s)

TPF induction chemotherapy

Other Intervention Name(s)

Followed by surgery and radiotherapy.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Survival rate

Description

To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.

Time Frame

Up to 5 years

Secondary Outcome Measure Information:

Title

local control

Description

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

Time Frame

Up to 5 yeas

Title

Number of participants with adverse events

Description

All adverse events, including serious adverse events, exposure of all study drugs and radiation.

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-yuan Zhang, MD, PhD

Organizational Affiliation

Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Official's Role

Study Chair

Facility Information:

Facility Name

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33471949

Citation

Ju WT, Liu Y, Wang LZ, Li J, Ren GX, Sun J, Tu WY, Hu YJ, Ji T, Yang WJ, Li J, He Y, Wang YA, Zhang CP, Zhong LP, Zhang ZY. Phase III trial of docetaxel cisplatin 5-fluorouracil induction chemotherapy for resectable oral cancer suggests favorable pathological response as a surrogate endpoint for good therapeutic outcome. Cancer Commun (Lond). 2021 Mar;41(3):279-283. doi: 10.1002/cac2.12136. Epub 2021 Jan 20. No abstract available.

Results Reference

derived

PubMed Identifier

32934722

Citation

Hu YJ, Sun WW, Zhao TC, Liu Y, Zhu DW, Wang LZ, Li J, Zhang CP, Zhang ZY, Zhong LP. Cyclin D1 overexpression enhances chemosensitivity to TPF chemotherapeutic agents via the caspase-3 pathway in oral cancer. Oncol Lett. 2020 Nov;20(5):154. doi: 10.3892/ol.2020.12015. Epub 2020 Aug 24.

Results Reference

derived

PubMed Identifier

24669014

Citation

Yang CZ, Ma J, Zhu DW, Liu Y, Montgomery B, Wang LZ, Li J, Zhang ZY, Zhang CP, Zhong LP. GDF15 is a potential predictive biomarker for TPF induction chemotherapy and promotes tumorigenesis and progression in oral squamous cell carcinoma. Ann Oncol. 2014 Jun;25(6):1215-22. doi: 10.1093/annonc/mdu120. Epub 2014 Mar 24.

Results Reference

derived

PubMed Identifier

23129742

Citation

Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. doi: 10.1200/JCO.2012.43.8820. Epub 2012 Nov 5.

Results Reference

derived

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

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