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Tongue CancerPhase 2NCT03161548

A Study of Tongue Conservation Surgery for Oral Tongue Cancer

A Phase 2 study testing Induction chemotherapy, Tongue conservation surgery and postoperative CCRT in people with Tongue Cancer and Chemotherapy Effect, run by Taipei Veterans General Hospital, Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential induction chemotherapy, tongue conservation surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral tongue cancer. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Tongue Cancer, Chemotherapy Effect, Surgery
What is being tested?
Induction chemotherapy, Tongue conservation surgery and postoperative CCRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
No sites listed yet
Study dates
18 Jul 2011to 4 Jan 2017
Phase
Phase 2
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histological proof of squamous cell carcinoma of oral tongue
  • b. cT2-4, N0-2,M0, by clinical or radiographic examinations
  • Either mandibulotomy, mandibulectomy or flap reconstruction is required by standard surgical planning
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Between 20 and 70 years of age
  • Adequate hematopoietic function as defined below:
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  • Hemoglobin >= 10g/dl Absolute neutrophil count (ANC) >= 1,500/µL Platelets >= 100,000/µL
  • Adequate organ function as defined below:
  • Total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine <= 1.5 x upper limit of normal Creatinine clearance > 50 ml/min
  • Signed study-specific consent form prior to study entry

Who cannot join

  • Patients received gross oral tongue tumor resection before evaluation
  • Primary subsites other than oral tongue
  • Histologic diagnosis other than squamous cell carcinoma
  • Patient with synchronous primary cancers (within 6 months)
  • Clinical or radiographic findings as below:
  • T1 tumors Gross invasion to mandible, tonsil or >1/3 base of tongue N3 disease or distant metastasis (M1)
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  • Prior head and neck chemotherapy or radiotherapy
  • Prior esophageal cancer history
  • Active cardiac disease defined as: unstable angina, uncontrolled arrhythmia, myocardial infarction within 6 months.
  • Severe chronic obstructive pulmonary disease (COPD) requiring ≥ 3 hospitalizations over the past year
  • Mental status not fit for clinical trial.
  • Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method.

About this study

Official title: A Phase II Study of Tongue Conservation Surgery for Advanced Oral Tongue Cancer: Induction Chemotherapy, Followed by Tongue Conservation Surgery and Postoperative Chemoradoitherapy

This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential induction chemotherapy, tongue conservation surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral tongue cancer.

Read the detailed description

Surgical resection remains the most important component of standard treatment for oral tongue cancer, but may lead to profound functional impacts not effectively compensated by reconstruction surgery. The volume of tongue resection remains one key factor for the post-treatment deterioration of the functional outcomes and quality of life in large oral tongue cancer. Primary chemoradiotherapy without surgical resection has not been accepted for oral tongue cancer because of the concerns about possible poorer response and sequelae. Breast conservation treatment, by the sequential use of induction chemotherapy (ICT), limited surgical resection and chemoradiotherapy, has become a standard treatment for human breast cancer of various stages. However, similar tongue conservation treatment for advanced oral tongue cancer has not been studied in trials. Based on these data, it will be reasonable, in locally advanced (> 3 cm) resectable oral tongue cancers, to test whether ICT followed by tongue conservation surgery and postoperative CCRT can safely enhance the possibility of tongue conservation with improved post-treatment functions.

Being tested
Induction chemotherapy, Tongue conservation surgery, postoperative CCRT
Medical subject headings
Tongue Neoplasms

What participants receive

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

  • Induction chemotherapyDrug

    All eligible subjects will receive ICT with DCU regimen every 21 days as follows:

    Docetaxel 36 mg/m2 intravenous infusion over 1 hr, followed by Cisplatin 30 mg/m2 intravenous infusion over 1 hr, on day 1 and day 8, Oral tegafur/uracil 300 mg/m2/day plus leucovorin 90 mg/day on days 1 - 14

  • Tongue conservation surgeryProcedure or surgery

    Surgical excision of residual oral tongue tumor will be performed in 3-4 weeks after the start of the last cycle of ICT. Neck dissection will also be done as indicated.

  • postoperative CCRTRadiation

    Post-op CCRT will be started 4-6 weeks after surgery, with regimen as follows:

    Radiotherapy in 2 Gy once-daily fraction size, Monday to Friday, with dose up to 60 Gy (total of 30 fractions); Cisplatin 25 mg/m2 intravenously for 4 hours every week a cycle to total 6 cycles; Tegafur/uracil (UFUR) 200 mg po bid for whole course of radiotherapy

Study groups in NCT03161548
Study groupRoleWhat they receive
Induction chemotherapyExperimentalInduction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
Receives: Drug: Induction chemotherapy; Procedure: Tongue conservation surgery; Radiation: postoperative CCRT

What is being measured

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

  1. Objective response rate

    Response to induction chemotherapy

    Measured: 2 weeks after completion of the last cycle of induction chemotherapy

Secondary outcomes (4)

  1. Tongue conservation surgery feasibility rates

    Feasibility of tongue conservation surgery

    Measured: the date of surgery

  2. Pathological response of induction chemotherapy

    Pathological evaluation of rediual tumor status

    Measured: 2 weeks after surgery

  3. Longitudinal quality of life (QOL)

    Evaluation of QOL with the EORTC-C30 and HN35 QOL questionnaires

    Measured: Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion

  4. Oncologic results

    Disease specific survival

    Measured: 5 years after treatment completion

Timeline

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

  1. First posted22 May 2017
  2. Study start18 Jul 2011
  3. Primary completion27 Jan 2016
  4. Study completion4 Jan 2017

Why it stopped: Diffiult patient recruitment

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential doxcetaxel, cisplatin and tegafur/uracil plus leucovorin (DCU) induction chemotherapy, tongue conservation surgery and postoperative CCRT in patients with advanced oral tongue cancer.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161548
Sponsor's protocol ID
201009018MB
Status last verified
May 2017
First submitted
17 May 2017
Last updated
30 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction chemotherapy, Tongue conservation surgery and postoperative CCRT in people with Tongue Cancer and Chemotherapy Effect, run by Taipei Veterans General Hospital, Taiwan.

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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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 was stopped early (reason given: Diffiult patient recruitment). Results are not available in the source record.

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?

Objective response rate (time frame: 2 weeks after completion of the last cycle of induction chemotherapy). 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 NCT03161548.

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 30 May 2017.

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