Squamous Cell Carcinoma of Oral Cavity
Conditions
Keywords
Tegafur-uracil, distant metastasis, oral cavity cancer
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.
Interventions
DRUGtegafur-uracil
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the 2-year distant failure rate | 2 years | the 2-year distant failure rate calculated from the date of surgery will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 2-year locoregional failure rate. | 2 years | the 2-year locoregional failure rate calculated from the date of surgery will be measured. |
| the 2-year overall survival (OS) rate | 2 years | the 2-year overall survival rate calculated from the date of surgery will be measured |
| the 2-year progression-free survival (PFS) rate | 2 years | the 2-year progression-free survival rate calculated from the date of surgery will be measured. |
| Incidence of Treatment-Emergent Adverse Events | 2 years | Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0 |
Countries
Taiwan
Contacts
Primary ContactHung-Ming Wang, M.D.
Backup ContactChia-Hsun Hsieh, M.D.
Outcome results
None listed