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

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

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.