Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+

February 10, 2019 updated by: Chang Gung Memorial Hospital

A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes

Primary Objective:

To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.

Secondary Objectives:

  • To determine the 2-year locoregional failure rate.
  • To evaluate the 2-year overall survival (OS) rate.
  • To evaluate the 2-year progression-free survival (PFS) rate.
  • To assess the safety profiles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary endpoint will be 2-years distant failure rate which will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.

The secondary endpoints are described as follows:

  • 2-year locoregional failure rate, 2-year PFS rate and 2-year OS rate will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.
  • Safety profile: adverse events will be summarized by CTCAE. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.

Determination of sample size:

The estimated 2-year distant failure rate for squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes is 26%. The 2-year distant failure rate of maintenance treatment with tegafur-uracil in this study is expected to be 13%. Using One Proportional Test with one-sided alpha 0.05 and power 80%, the sample size of 56 subjects will test an effect size of 13% (i.e. 26% vs.13%). With expected dropout rate of 20%, the sample size would be 68 subjects.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hung-Ming Wang, M.D.
  • Phone Number: 8820 +886 33281200
  • Email: whm526@gmail.com

Study Contact Backup

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang-Gung Memorial Hospital-Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have histologically confirmed squamous cell carcinoma with primary site in the oral cavity.
  • Patient must have no distant metastasis in the pre-adjuvant radiotherapy evaluation.
  • Patient must have received surgical treatment with pathologically documented extracapsular spreading of lymph node.
  • Patient must have no CTCAE 4.0 grading≧2 acute adverse events from previous definite treatment at enrollment.
  • Patient must can be enrolled within 1 to 3 months after definite treatment.
  • Age between 20 and 70 years old;
  • Patient must have ECOG performance status score 0 or 1;

  • Patient must have adequate hematopoietic function which is defined as below:

    1. white blood cell (WBC) ≥ 4,000/mm3;
    2. platelet count ≥ 100,000/mm3;
    3. absolute neutrophil count (ANC) ≥ 1,500/mm3;

  • Patients must have adequate hepatic function which is defined as below:

    1. serum bilirubin level < 1.5 mg/dl;
    2. sGOT and sGPT < 2.5 x ULN;
    3. serum creatinine level < 1.5 x ULN;
  • All women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study medication;
  • Patient with childbearing potential must agree to use a reliable contraceptive method during their participation in the study;
  • Patient must have the ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patient who has distant metastasis;
  • Patient who has serious concomitant illness which might be aggravated by chemotherapy;
  • Other malignancy within 5 years prior to study entry with exception of curative treated basal or squamous cell skin cancer or cervical carcinoma in situ.
  • Female patient who is pregnant or breast feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maintenance

Eligible patient will be given maintenance tegafur-uracil for one year.

Dose of tegafur-uracil will be based on patient's body surface area (BSA):

  • BSA < 1.5 m2: tegafur-uracil 300 mg/day (1 capsule three times a day)
  • BSA ≥ 1.5 m2: tegafur-uracil 400 mg/day (2 capsules twice a day) Tegafur-uracil will be started after patient has complete the adjuvant radiotherapy and been enrolled into the study.
Drug: tegafur-uracil
Other Names:
  • UFUR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 2-year distant failure rate
Time Frame: 2 years
the 2-year distant failure rate calculated from the date of surgery will be measured
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 2-year locoregional failure rate.
Time Frame: 2 years
the 2-year locoregional failure rate calculated from the date of surgery will be measured.
2 years
the 2-year overall survival (OS) rate
Time Frame: 2 years
the 2-year overall survival rate calculated from the date of surgery will be measured
2 years
the 2-year progression-free survival (PFS) rate
Time Frame: 2 years
the 2-year progression-free survival rate calculated from the date of surgery will be measured.
2 years
Incidence of Treatment-Emergent Adverse Events
Time Frame: 2 years
Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hung-Ming Wang, M.D., Chang Gung Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2015

Primary Completion (Anticipated)

May 11, 2020

Study Completion (Anticipated)

May 11, 2020

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-0621A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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