NCT03121313

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

February 26, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
Last Updated

February 12, 2019

Status Verified

September 1, 2018

Enrollment Period

5.2 years

First QC Date

April 17, 2017

Last Update Submit

February 10, 2019

Conditions

Squamous Cell Carcinoma of Oral Cavity

Keywords

Tegafur-uracildistant metastasisoral cavity cancer

Outcome Measures

Primary Outcomes (1)

  • the 2-year distant failure rate

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

    2 years

Secondary Outcomes (4)

  • the 2-year locoregional failure rate.

    2 years

  • the 2-year overall survival (OS) rate

    2 years

  • the 2-year progression-free survival (PFS) rate

    2 years

  • Incidence of Treatment-Emergent Adverse Events

    2 years

Study Arms (1)

Maintenance

EXPERIMENTAL

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

Interventions

tegafur-uracilDRUG
Also known as: UFUR
Maintenance

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Gung Memorial Hospital-LinKou

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (6)

  • Liao CT, Chang JT, Wang HM, Ng SH, Hsueh C, Lee LY, Lin CH, Chen IH, Huang SF, Cheng AJ, Yen TC. Analysis of risk factors of predictive local tumor control in oral cavity cancer. Ann Surg Oncol. 2008 Mar;15(3):915-22. doi: 10.1245/s10434-007-9761-5. Epub 2007 Dec 29.

    PMID: 18165878BACKGROUND

  • Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

    PMID: 15128893BACKGROUND

  • 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.

    PMID: 11735172BACKGROUND

  • 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.

    PMID: 8031158BACKGROUND

  • 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.

    PMID: 15128894BACKGROUND

  • 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.

    PMID: 20934267BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckMouth Neoplasms

Interventions

Tegafur

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hung-Ming Wang, M.D.

    Chang Gung Medical Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Ming Wang, M.D.

CONTACT

+886 33281200whm526@gmail.com

Chia-Hsun Hsieh, M.D.

CONTACT

+886 33281200wisdom5000@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 20, 2017

Study Start

February 26, 2015

Primary Completion

May 11, 2020

Study Completion

May 11, 2020

Last Updated

February 12, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)