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A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC).

ABSTRACT: Intervention name : UFT(tegafur + uracil) INN of the intervention : UFT:tegafur, uracil Dosage And administration of the intervention : oral uracil-tegafur 400 mg square meter for one year Primary outcome(s): Efficacy and safety Study Design: Randomized, comparative study

DISEASE(S): Bowel Cancer

PROVIDER: 2609887 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC).

Project description:Interventions: investigational material(s) Generic name etc : UFT(tegafur + uracil) INN of investigational material : UFT:tegafur, uracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : oral uracil-tegafur 400 mg square meter for one year Primary outcome(s): Efficacy and safety Study Design: Randomized, comparative study

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Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy for the Stage II, III colorectal cancer

Project description:Interventions: Tegafur/uracil with oral leucovorin(UFT/LV) UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. Primary outcome(s): Quality of Life Study Design: Single arm Non-randomized

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Adjuvant tegafur-uracil (UFT) or S-1 monotherapy for advanced gastric cancer: a single center experience.

Project description: Not available

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Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

Project description:Intervention name : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin) INN of the intervention : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin Dosage And administration of the intervention : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. Control intervention name : UFT(tegafur + uracil) LV (Folic acid) INN of the control intervention : UFT: tegafur, uracil LV:folic acid Dosage And administration of the control intervention : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment. Primary outcome(s): efficacy Disease-free survival (DFS) Study Design: Randomized, open-label, comparative study

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A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

Project description:This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

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A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

Project description:To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

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Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery

Project description:RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer. PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

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Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer

Project description:Colorectal cancer is a major health problem in Western society contributing to a high mortality rate. Treatment options for the majority of patients with metastases are limited to cytotoxic chemotherapies. The first line chemotherapy containing with oxaliplatin is recommend by guideline. The use of antiangiogenic agents, either alone or in combination with other therapies may provide an alternative treatment modality in the management of these patients. Metronomic chemotherapy refers to the close, regular administration of a chemotherapeutic drug, over prolonged periods. The advantages of metronomic chemotherapy include reducing acute toxicities and sometimes surprisingly good activity against drug resistant tumors via antiangiogenic effect. Thalidomide is an agent, which has shown potential in the treatment of hematological and solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism. Tegafur/uracil (UFUR) is one of the effective chemotherapeutics reported to be an effective antiangiogenic agent in an animal model of metastatic colorectal cancers (CRCs). In the present study, the investigators will try to use low dose metronomic schedule of thalidomide with tegafur/uracil regimen to see the anti tumor efficacy in recurrent and metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy. The primary endpoints are overall response rate and clinical benefit and the secondary endpoint were to determine the progression free survival, and duration of objective response, the overall survival (OS) and to assess the safety profile. This is a prospective phase II study. After having checked all eligibility criteria, patients will be treated with Tegafur/Uracil (TU) regimen. About 34 patients will be enrolled.

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Sorafenib plus tegafur-uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study).

Project description: Not available

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Maintenance treatment of Uracil and Tegafur (UFT) in responders following first-line fluorouracil-based chemotherapy in metastatic gastric cancer: a randomized phase II study.

Project description: Not available

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