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A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer (SOAC-1101)

SOAC-1101 (SOAC-1101)

159

The background of the subjects in each group of UFT / LV group: TEGAFOX group was median age 66 years: 65.5 years, male-female ratio 23:53 and 26:50, colon as primary tumor site: rectum 60: 16 and 59:17, StageII: StageIII were 19:17 and 17:59.

Case registration was carried out from 18 institutions from April 2010 to April 2015. The study was conducted on 159 patients with colorectal cancer who underwent curative resection of high-risk Stage II and Stage III. A safety analysis was performed on 154 patients, excluding a total of 5 patients, including 1 patient who refused after obtaining consent, 1 case who did not obtain consent text, and 3 cases who did not undergo study treatment. Furthermore, the 3-year disease-free survival time was compared and examined in 151 patients excluding a total of 3 patients, 2 patients who received treatment different from the study treatment and 1 patient who withdrew consent during the study treatment period. 76 patients were assigned to the UFT / LV group and 75 patients were assigned to the TEGAFOX group. The primary endpoint was 3-year disease-free survival, and the secondary endpoints were treatment completion rate, adverse event incidence, and 5-year survival rate.

Adverse events due to study treatment were observed in 133 of all cases, 86.4%. UFT / LV group: The adverse events in each group of the TEGAFOX group were 59 (76.6%): 74 (96.1%), and the incidence of Grade 3/4 of NCI-CTCAE ve.4.0 was 10 (13.0%): 20. It was (20.8%). Neutropenia (2.6%: 19.5%), thrombocytopenia (7.8%: 36.4%), AST elevation (19.5%: 39.0%), ALT elevation (14.3%: 35.1%) compared between each group in all Grades %), Loss of appetite (13.0%: 32.5%), peripheral neuropathy (1.3%: 59.7%) and TEGAFOX group had significantly more adverse events, but Grade 3/4 showed no significant difference between each group. It was.

The primary endpoint is 3-year disease-free survival, with 84.2% (95% CI; 73.9-90.7): 62.1 (95% CI; 50.0-72.1) in the UFT / LV group: TEGAFOX group, log-rank. The test by test showed p <0.01, and the TEGAFOX group performed significantly better. The treatment completion rate as a secondary endpoint was 77.6%: 77.6% in the UFT / LV group: TEGAFOX group, and the treatment discontinuation rate in adverse events was 17.1%: 22.4%.

Registered from 18 facilities from April 2010 to April 2015. A study was conducted on 159 patients with colorectal cancer who underwent curative resection of high-risk Stage II and Stage III, of which 154 had a safety analysis and 151 had a 3-year disease-free survival comparison. 76 patients were assigned to the UFT / LV group and 75 patients were assigned to the TEGAFOX group. The 3-year disease-free survival was 84.2% (95% confidence interval; 73.9-90.7): 62.1 (95% confidence interval; 50.0-72.1) in the

Feb. 28, 2022

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs031180381

Matsubara Hisahiro

Chiba University Hospital

1-8-1Inohana, chuo-ku, Chiba-shi, Chiba

matsuhm@faculty.chiba-u.jp

Miyauchi Hideaki

Chiba surgical oncology development association

1-8-1 Inohana, Chuo-ku, Chiba, Japan

+81-43-226-2109

miyahide@faculty.chiba-u.jp

Complete

June. 01, 2011

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

1) Confirmed adenocarcinoma
2) High risk stage II or stage III colorectal cancer
3) Recieved curative resction
4) 20 years old or older
5) PS(ECOG) 0 or 1
6) No previous treatment exclude surgery
7) Oral intake is possible
8) Adequate organ fanction
9) Treatment can start within eight weeks after surgery.
10) Written informed consent

1) Serious diarrea
2) Serious postoperative complications
3) Serious drug hypersensitivity
4) Pregnant or nursing
5) Serious coexisting illness
1; diabetes mellitus, uncontrolled or controlled with insulin
2; uncontrolled hypertension
3; liver cirrhosis
4; renal disfaunction
5; severe pulmonary dysfunction
6; active infection
7; history of myocardial infarction, unstable angina within 6 months prior to the registration
6) Active synchronous or metachronous malignancy other than carcinoma in situ
7) Sensory neuropathy
8) Severe mental disorders
9) Not suitable for participating in the study for any other reason

Both

high risk stage II/ stage III colorectal cancer

UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
Oxaliplatin gives 85 mg/m2 intravenously on 1,15 day of each course.

Colorectal Cancer

3-year desiese free survival rate

Overall Survival
Adverse event / Percentage of occurrence of side effects
Percent of administration completed

+81-43-226-2616

Feb. 20, 2019

none