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

• Status: Unknown status
• Trial end date: 2020-05-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Tegafur

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.