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| ID | Type | Description | Link |
|---|---|---|---|
| TMDU-TRICC0706 | Other Identifier | National Cancer Institute |
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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.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Biological samples are collected for gene expression analysis for identification of predictive markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tegafur-gimeracil-oteracil potassium | Experimental | Patients receive tegafur-gimeracil-oteracil potassium(S-1) orally twice daily for 28 days with a subsequent pause of 14 days. This repeats 4 times every 6 weeks. |
|
| tegafur-uracil and folinate calcium | Active Comparator | Patients receive tegafur-uracil(UFT) plus folinate calcium(leucovorin) orally every 8 hours for 21 days with a subsequent pause of 7 days. This repeats 5 times every 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folinate calcium | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Adverse event | ||
| Pharmaco-economics |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of colon
Has undergone surgical resection of the tumor within the past 8 weeks
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Able to take medications orally
WBC ≥ 3,500/mm³ and < 12,000/mm³
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 2.0 mg/dL
AST/ALT ≤ 100 IU/L
Creatinine ≤ 1.2 mg/dL
No other active malignancies
Must have none of the following comorbidities:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kenichi Sugihara, MD, PhD | Tokyo Medical and Dental University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University | Tokyo | Tokyo | 113-8519 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30425843 | Derived | Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, Inoue T, Nakamoto Y, Shiomi A, Takagane A, Sunami E, Shinozaki H, Takii Y, Maeda A, Ojima H, Hashida H, Mukaiya M, Yokoyama T, Nakamura M, Munemoto Y, Sugihara K. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer. ESMO Open. 2018 Oct 7;3(6):e000428. doi: 10.1136/esmoopen-2018-000428. eCollection 2018. | |
| 24942277 |
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| tegafur-uracil |
| Drug |
|
|
| tegafur-gimeracil-oteracil potassium | Drug |
|
|
| Identification of predictive markers |
| Derived |
| Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K; ACTS-CC study group. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial). Ann Oncol. 2014 Sep;25(9):1743-1749. doi: 10.1093/annonc/mdu232. Epub 2014 Jun 18. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005641 | Tegafur |
| C079198 | S 1 (combination) |
| C103828 | titanium silicide |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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