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

NCT ID: NCT03121313

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-26
• Study Completion Date: 2020-05-11

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.

Conditions

Squamous Cell Carcinoma of Oral Cavity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tegafur-uracil

Intervention Type: DRUG

Interventions

tegafur-uracil

Intervention Type: DRUG

Other Intervention Names

UFUR

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:

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Ming Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation

Locations

Chang-Gung Memorial Hospital-LinKou

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Ming Wang, M.D.

Role: CONTACT

whm526@gmail.com

+886 33281200 ext. 8820

Chia-Hsun Hsieh, M.D.

Role: CONTACT

wisdom5000@gmail.com

+886 33281200 ext. 8820

References

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.

Reference Type: BACKGROUND

PMID: 18165878 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 8031158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15128894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20934267 (View on PubMed)

Other Identifiers

103-0621A3

Identifier Type: -

Identifier Source: org_study_id