Study of resection of primary colorectal caner and synchronous liver metastasis after SOX + Bmab

JRCT ID: jRCTs021180034

Registered date:25/03/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: colorecal cancer
• Date of first enrollment: 04/04/2018
• Target sample size: 28
• Study type: Interventional
• Intervention(s): S-1 is administered orally at 80mg/m2/day for 14 consecuitive days followed by a 7 day rest. L-OHP is given intravenously on days 1, at a dose of 130mg/m2/day.Bevacizumab is given intravenously on days 1, at a dose of 7.5mg/kg/day. 21 days are assumed 1 course, and chemotherapy consisted of 4 courses. Surgery is carried out in 8 to 12 weeks after the end of chemotherapy.

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: Overall survival, Relapse-free survival, R0 rate of primary tumor, R0 rate of liver metastasis, Reoperation rate, Completion rate of S-1 + oxaliplatin + bevacizumab, Safety, Efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Hitologically confirmed colon or rectal cancer
2) With priary lesion on colon or rectal cancer
3) With primary and synchronous liver metastasis without other metastasis
4) With evaluable lesion
5) Where a surgeon judged hepatectomy is possible. As a measure of initially unresectable liver metastasis, it is assumed that the residual liver volume after hepatectomy is expected to be less than 30% even by portal vein embolism
6) Without extrahepatic lesions other than the primary lesion
1. Without pulmpnary metastasis by X-P or CT
2. Without hepatic and paraaortic lymph node swelling by CT
7) Age of 20-75 years
8) Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
9) Aadequate function of important organs
1. WBC: >=3,000/mm3 and 12,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T Bil: <=2.0mg/dL
6. AST, ALT: <100IU/L
7. Serum creatinine: <=1.2mg.DL
8. Creatinin clearance level >= 60mi/min
9. Urine protein<=1+
10. INR<=1.5
10) ECG: without clinically problematic abnormalities within 28 days before registration
11) Eastern Cooperative Oncology Group performance status (PS) 0-1
12) With ability of oral intake
13) Established stoma because of a primary lesion accompanied with high stenosis that does not allow the endoscope to pass
14) Written informed concent

Exclude criteria

1) with gastrointestinal ulceration or bleeding
2) with sensory neuropathy
3) with severe diarrhea
4) had a previous serious drug allergies
5) had pleural effusion or ascites which need therapy
6) with brain metastasis or suspected the brain metastases
7) had surgery within 28 days before registration
8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
10) with active double cancer
11) had active infection disease (over 38.0 degree)
12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris)
13) receiving Flucytosine
14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant
15) had hemoptysis (2.5 ml or more of fresh blood)
16) had gastrointestinal perforation within 6 months
17) were systemically-administered of steroids
18) with contraindications to TS-1, L-OHP, and Bevacizumab
19) with HBsAg-positive
20) Physician will determine that the patient is inappropriate participate in this trail for the safety.

Related Information

• Primary Sponsor: Morohashi Hajime