JFMC46-1201

Phase 3

• Conditions: StageII colorectal cancer

• Registration Number: JPRN-jRCTs031180155
• Lead Sponsor: Okada Kazutake

Brief Summary

Adjuvant chemotherapy with UFT/LV significantly improves DFS and shows an acceptable safety profile for stage II colon cancer with risk factors.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Study Completion: 2021-12-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1938

Inclusion Criteria

A patient:
1)with histologically confirmed colorectal cancer.
2)with histologically confirmed Stage II(T3-4,N0,M0)(TNM classification,UICC,Vol.7,2009)colorectal cancer(which is C,A,T,D or S)and rectal cancer(which is only RS).
3)has at least one of the following factors
-T4
-Perforation, Penetration
-Poorly differentiated adenocarcinoma
-Mucinous carcinoma
-Lymph node dissection: less than 12
4)underwent R0 resection.
5)is at the age of 20 to 80 at the time of registration.
6)whose Performance status(ECOG)is 0 or 1.
7)hasn't received any treatment other than R0 resection.
8)can take drugs orally.
9)whose sufficient functions of main organ should be confirmed by the clinical test within 14 days before registration as follows:
i. WBC:>=3,000/mm3,<12,000/mm3
ii. neutrophil:>=1,500/mm3
iii. blood platelet:>=100,000mm3
iv. hemoglobin:>=9.0g/dL
v. total bilirubin:=2.0mg/dL
vi. AST(GOT):<=100IU/L
vii. ALT(GPT):<=100IU/L
viii. Scr:<1.5mg/dL
10)can start the therapy within 8 weeks after surgery.
11)whose written consent is taken.

Exclusion Criteria

A patient:
1)with administration contraindications for UFT,LV.
2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
3)has severe postoperative complications such as serious postoperative infectious disease, anastomotic leak and gastrointestinal bleeding.
4)has any of the following complications:
i. Uncontrollable diabetes mellitus
ii. Uncontrollable hypertension
iii. liver cirrhosis, liver failure
iv. renal failure
v. interstitial pneumonitis, lung fibrosis or severe emphysema
vi. active infection
vii. heart failure within 6 months, myocardial infarction, AP or sever abnormality of ECG
5)has severe diarrhea.
6)has severe drug hypersensitivity.
7)is a pregnant woman or a woman suspected of being pregnant, or, is a man who hopes to make his partner pregnant.
8)with psychosis or psychoneurosis.
9)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified