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

Squamous Cell Carcinoma of Oral Cavity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03121313
• Other study ID #: 103-0621A3
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2015
• Est. completion date: May 11, 2020

Study information

• Verified date: September 2018
• Source: Chang Gung Memorial Hospital
• Contact: Hung-Ming Wang, M.D.
• Phone: +886 33281200
• Email: whm526[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 11, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Squamous Cell Carcinoma of Oral Cavity

Intervention

Drug:
• tegafur-uracil

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital-LinKou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 2-year distant failure rate	the 2-year distant failure rate calculated from the date of surgery will be measured	2 years
Secondary	the 2-year locoregional failure rate.	the 2-year locoregional failure rate calculated from the date of surgery will be measured.	2 years
Secondary	the 2-year overall survival (OS) rate	the 2-year overall survival rate calculated from the date of surgery will be measured	2 years
Secondary	the 2-year progression-free survival (PFS) rate	the 2-year progression-free survival rate calculated from the date of surgery will be measured.	2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0	2 years