JFMC46-1201

JRCT ID: jRCTs031180155

Registered date:25/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: StageII colorectal cancer
• Date of first enrollment: 07/05/2012
• Target sample size: 2820
• Study type: Interventional

Intervention(s)

UFT/LV as postoperative adjuvant chemotherapy for the stage II colorectal cancer is tested as follows: one patient group for 28 days with 7 days rest (everyday medication) and another patient group for 5days with 2days rest (5-days on/2-days, Saturday and Sunday, off). Both medications are conducted for 25weeks as 5 courses (1 course=5weeks, 35days) from the date of the start of the therapy. After the treatment, both patient groups are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.
The surgery alone group is simply observed without therapy, unless any recurrent lesions or any other cancer lesions (synchronous cancers or multiple colorectal cancers) are observed in them.

Outcome(s)

• Primary Outcome: Disease-free survival

Secondary Outcome

Overall survival,
Adverse events,
Investigation of the efficacy for UFT/LV and the prognosis by the presence of CEA mRNA-positive later than 24 hours after surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Okada Kazutake
• Secondary Sponsor: Sadahiro Soutarou
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD
• Secondary ID(s): UMIN000007783