Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer(SOAP trial)

JRCT ID: jRCTs031180109

Registered date:07/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 30/04/2014
• Target sample size: 160
• Study type: Interventional

Intervention(s)

arm A: L-OHP 100mg/m2, 8 courses (24 weeks)
1) 2 hour bolus infusion of 100mg/m2 of L-OHP on day1
2)According to BSA, from 80mg to 120mg of S-1 is taken divided twice a day from day 1 to day 15.
3) Period of one course is 21 days, 8 courses(24 weeks) is performed.
arm B: L-OHP 130mg/m2, 4 courses (12 weeks)
1) 2 hour bolus infusion of 130mg/m2 of L-OHP on day1
2)According to BSA, from 80mg to 120mg of S-1 is taken divided twice a day from day 1 to day 15.
3) Period of one course is 21 days, 4 courses(12 weeks) is performed

Outcome(s)

• Primary Outcome: Disease free survival

Secondary Outcome

1)Relative Dose Intensity
2)completion rate
3)Relapse free survival
4)Overall survival
5)time-dependent change of peripheral neuropathy
6)Adverse event rate

Key inclusion & exclusion criteria

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

Include criteria

1) clinical stage II, III
2) tumor location is from cecum to rectosigmoid.
3) aged between 20 and 80 years old
4) ECOG Performance status of 0 or 1
5) no prior chemotherapy or radiotherapy
6) oral intake is possible
7) adequate bone marrow function with absolute neutrophil count >=1,500/microl, platelet count >=100,000/microl, adequate liver function with total bilirubin =<2 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) =<100IU/L, adequate renal function with Ccr >= 60ml/min
8) Able to start protocol treatment within 8 weeks of surgical procedure.
9) willing to provide written informed consent.

Exclude criteria

1) Tumor located below the peritoneum.
2) history of another malignancy within 5 years
3) Severe postoperattive complication (such as severe infection, severe anastomoitc leakage, intestinal bleeding)
4) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure.
5) Severe sensory disorder
6) Severe diarrhea
7) history of severe drug hypersensitivity
8) administration of flucytosine
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
10) Severe psychiatric disorder
11) Physician concludes that the patient's participation in this trial is inappropriate.

Related Information

• Primary Sponsor: Watanabe Jun
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.
• Secondary ID(s): UMIN000013825