Study of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection

JRCT ID: jRCTs021180033

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rectal cancer
• Date of first enrollment: 01/11/2015
• Target sample size: 55
• 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 adose of 130mg/m2/day. 21 days are assumed 1 course, and neoadjuvant chemotherapy consisted of 3 courses. Surgery is carried out in 3 to 8 weeks after the end of chemotherapy.

Outcome(s)

• Primary Outcome: cumulative local recurrence rate
• Secondary Outcome: Relapse free survival, Overall survival, Treatment completion rate, Down-staging rate, Safety, sphincter-preservation rate, time from definite diagnosis to initiation of therapy

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically confirmed Rectum adenocarcinoma
2) Adequate following in the diagnostic imaging within 28 days before registration
-Clinical stage T3, any N, or T4, any N
-Main lesion of the tumor is located at the Ra or Rb
-The edge of tumor is lower than the peritoneal reflection
-Not diffuse infiltrating carcinoma.
3) Without liver, peritoneum and distant metastases
4)Age of 20-80 years
Possigle to R0 resection
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
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) experienced severe drug allergies in the past
16) were systemically-administered of steroids
17) with contraindications to TS-1 and L-OHP
18) with HBsAg-positive
19) Physician will determine that the patient is inappropriate participate in this trail for the safety.

Related Information

• Primary Sponsor: Morohashi Hajime