Clinical trial · Interventional
Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+
A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
NCT03121313CI-TRIAL-00037052unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tegafur-uracil | Drug | Tegafur | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maintenance
- description
- 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.
- interventionNames
- Drug: tegafur-uracil
Primary outcomes (1)
- measure
- the 2-year distant failure rate
- timeFrame
- 2 years
- description
- the 2-year distant failure rate calculated from the date of surgery will be measured
Secondary outcomes (4)
- measure
- the 2-year locoregional failure rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDLiao 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. PMID 18165878
- BACKGROUNDCooper 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. PMID 15128893
- BACKGROUNDLam 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. doi: 10.1053/ejso.2001.1171. PMID 11735172
- BACKGROUNDTsukuda 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. PMID 8031158
- BACKGROUNDBernier 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. PMID 15128894
- BACKGROUNDLiao 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.