Surgery after SOX+Bmab for unresectable rectal cancer by organ-preserved TME

JRCT ID: jRCTs021180023

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: rectal cancer
• Date of first enrollment: 27/04/2018
• Target sample size: 32
• 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: T down-staging rate
• Secondary Outcome: Cumulative local recurrence rate, Relapse-free survival, Overall survival, pCR rate, N down-staging rate, Local response rate, mrTRG, Adverse event rate, Treatment-related death rate, Surgical complications rate, Organ sparing rate, R0 rate, The incidence of stoma dependence one year after operation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Histologically confirmed Rectum adenocarcinoma
2) Adequate following in the diagnostic imaging within 28 days before registration
1. Clinical stage T3, any N, or T4, any N
2. The edge of tumor is lower than Ra, Rb, P (Within 12cm from anal verge)
3. Unresectable rectal cancer by organ-sparing TME which was judged by high resolutoin MRI
-CRM<=1mm
-T4b
-Lateral lymph node metastasis
3) Without liver, peritoneum and distant metastases
4)Age of 15-75 years
5)Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
6)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
7) ECG: without clinically problematic abnormalities within 28 days before registration
8) Eastern Cooperative Oncology Group performance status (PS) 0-1
9) With ability of oral intake
10) 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: Miura Takuya