NCT01542931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

August 21, 2017

Status Verified

February 1, 2012

Enrollment Period

7.9 years

First QC Date

February 26, 2012

Last Update Submit

August 16, 2017

Conditions

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

Keywords

Oral squamous cell carcinomaInduction chemotherapySurgeryRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Survival rate

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

    Up to 5 years

Secondary Outcomes (2)

  • local control

    Up to 5 yeas

  • Number of participants with adverse events

    Up to 5 years

Study Arms (2)

Surgery and radiotherapy

NO INTERVENTION

Surgery and post-operative radiotherapy.

TPF induction chemotherapy

EXPERIMENTAL

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

Drug: TPF induction chemotherapy

Interventions

TPF induction chemotherapyDRUG

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.

Also known as: Followed by surgery and radiotherapy.
TPF induction chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (4)

  • 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.

    PMID: 33471949DERIVED

  • 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.

    PMID: 32934722DERIVED

  • 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.

    PMID: 24669014DERIVED

  • 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.

    PMID: 23129742DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Zhi-yuan Zhang, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ninth People's Hospital, School of Medicine

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 2, 2012

Study Start

January 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 31, 2015

Last Updated

August 21, 2017

Record last verified: 2012-02

Locations

CN(1)