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

Primary Purpose

Squamous Cell Carcinoma of Oral Cavity

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
tegafur-uracil
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Oral Cavity focused on measuring Tegafur-uracil, distant metastasis, oral cavity cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang-Gung Memorial Hospital-LinKouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maintenance

Arm Description

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.

Outcomes

Primary Outcome Measures

the 2-year distant failure rate
the 2-year distant failure rate calculated from the date of surgery will be measured

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2017
Last Updated
February 10, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03121313
Brief Title
Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+
Official Title
A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2015 (Actual)
Primary Completion Date
May 11, 2020 (Anticipated)
Study Completion Date
May 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Oral Cavity
Keywords
Tegafur-uracil, distant metastasis, oral cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tegafur-uracil
Other Intervention Name(s)
UFUR
Primary Outcome Measure Information:
Title
the 2-year distant failure rate
Description
the 2-year distant failure rate calculated from the date of surgery will be measured
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the 2-year locoregional failure rate.
Description
the 2-year locoregional failure rate calculated from the date of surgery will be measured.
Time Frame
2 years
Title
the 2-year overall survival (OS) rate
Description
the 2-year overall survival rate calculated from the date of surgery will be measured
Time Frame
2 years
Title
the 2-year progression-free survival (PFS) rate
Description
the 2-year progression-free survival rate calculated from the date of surgery will be measured.
Time Frame
2 years
Title
Incidence of Treatment-Emergent Adverse Events
Description
Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: white blood cell (WBC) ≥ 4,000/mm3; platelet count ≥ 100,000/mm3; absolute neutrophil count (ANC) ≥ 1,500/mm3; Patients must have adequate hepatic function which is defined as below: serum bilirubin level < 1.5 mg/dl; sGOT and sGPT < 2.5 x ULN; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Ming Wang, M.D.
Phone
+886 33281200
Ext
8820
Email
whm526@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hsun Hsieh, M.D.
Phone
+886 33281200
Ext
8820
Email
wisdom5000@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Ming Wang, M.D.
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Gung Memorial Hospital-LinKou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18165878
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
11735172
Citation
Lam P, Yuen AP, Ho CM, Ho WK, Wei WI. Prospective randomized study of post-operative chemotherapy with levamisole and UFT for head and neck carcinoma. Eur J Surg Oncol. 2001 Dec;27(8):750-3. doi: 10.1053/ejso.2001.1171.
Results Reference
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PubMed Identifier
8031158
Citation
Tsukuda M, Ogasawara H, Kaneko S, Komiyama S, Horiuchi M, Inuyama Y, Uemura T, Uchida M, Kamata S, Okuda M, et al. [A prospective randomized trial of adjuvant chemotherapy with UFT for head and neck carcinoma. Head and Neck UFT Study Group]. Gan To Kagaku Ryoho. 1994 Jul;21(8):1169-77. Japanese.
Results Reference
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PubMed Identifier
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Citation
Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
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PubMed Identifier
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Citation
Liao CT, Lee LY, Huang SF, Chen IH, Kang CJ, Lin CY, Fan KH, Wang HM, Ng SH, Yen TC. Outcome analysis of patients with oral cavity cancer and extracapsular spread in neck lymph nodes. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):930-7. doi: 10.1016/j.ijrobp.2010.07.1988. Epub 2010 Oct 8.
Results Reference
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Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+

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