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)

Phase 2

• Conditions: colon cancer

• Registration Number: JPRN-jRCTs031180109
• Lead Sponsor: Watanabe Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival

Secondary Outcome Measures

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