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Stage III Oral Cavity Squamous Cell CarcinomaPhase 2/3NCT01542931

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

A Phase 2/3 study testing TPF induction chemotherapy in people with Stage III Oral Cavity Squamous Cell Carcinoma and Stage IVA Oral Cavity Squamous Cell Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TPF induction chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteChina
Study dates
Jan 2008to 31 Dec 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Creatinine Clearance < 30 ml/min
  • Legal incapacity or limited legal capacity
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

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.

Read the 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.

Being tested
TPF induction chemotherapy
Keywords
Oral squamous cell carcinoma, Induction chemotherapy, Surgery, Radiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPF induction chemotherapyDrug

    Also called Followed by surgery and radiotherapy.

    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.

Study groups in NCT01542931
Study groupRoleWhat they receive
Surgery and radiotherapyNo interventionSurgery and post-operative radiotherapy.
TPF induction chemotherapyExperimentalInduction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.
Receives: Drug: TPF induction chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate

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

    Measured: Up to 5 years

Secondary outcomes (2)

  1. 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

    Measured: Up to 5 yeas

  2. Number of participants with adverse events

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

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2012 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2015
  4. Study completion31 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01542931
Sponsor's protocol ID
TPF for resectable OSCC
Other IDs
2007BAI18B03
Status last verified
Feb 2012
First submitted
26 Feb 2012
Last updated
21 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33471949

  • 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.

    PubMed 32934722

  • 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.

    PubMed 24669014

  • 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.

    PubMed 23129742

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TPF induction chemotherapy in people with Stage III Oral Cavity Squamous Cell Carcinoma and Stage IVA Oral Cavity Squamous Cell Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542931, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.

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