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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | UFT (uracil, tegafur) |
|
| 2 | Other | Surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UFT (uracil, tegafur) | Drug | to receive oral uracil-tegafur 400 mg square meter for one year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival and overall survival | every course for first three courses, then every other course |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | any time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeaki Yoshida, MD | National Cancer Center Hospital East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | 6-5-1, Kashiwanoha, Kashiwa, Chiba | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20490797 | Background | Hamaguchi T, Shirao K, Moriya Y, Yoshida S, Kodaira S, Ohashi Y; NSAS-CC Group. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol. 2011 Mar;67(3):587-96. doi: 10.1007/s00280-010-1358-1. Epub 2010 May 19. | |
| 16675478 | Result | Akasu T, Moriya Y, Ohashi Y, Yoshida S, Shirao K, Kodaira S; National Surgical Adjuvant Study of Colorectal Cancer. Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol. 2006 Apr;36(4):237-44. doi: 10.1093/jjco/hyl014. Epub 2006 May 4. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D005641 | Tegafur |
| D014498 | Uracil |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Surgery alone |
| Procedure |
Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer. |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006571 |
| Heterocyclic Compounds |