Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)

Phase 2

• Conditions: rectal cancer

• Registration Number: JPRN-UMIN000011486
• Lead Sponsor: Kyushu Study group of Clinical Cancer(KSCC)

Brief Summary

ASCO 2017(2017/6/2~6CHICAGO,ILLINOIS in USA) A Randomized PhaseII Study Evaluating Efficacy and Safety of SOX versus mFOLFOX6 as Neoadjuvant Chemotherapy for Patients with Resectable Rectal cancer(KSCC1301)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of serious drug hypersensitivity or a history of drug allergy 2) Pregnant or lactating woman and man who hope for Partner's pregnant 3) Active infection(over 38 degree) 4) Blood transfusion within 14 days before registration 5) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension) 6) Clinically significant abnormal electrocardiogram or heart disease 7) Serious diarrhea 8) Pleural effusion, peritoneal fluid that needs treatment 9) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 10) Hemorrhagic diathesis, coagulation disorder 11) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less). 12) Patients who need flucytosine, phenytoin or warfarin potassium. 13) Requiring steroid drug 14) Patients with contraindication to therapy 15) History of allergy to contrast material 16) Serious stricture (exclude the patients who are put in stoma) 17) Positive for HBs antigen and HCV antibody 18) Not appropriate for the study at the physician's assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-years Disease free survival rate

Secondary Outcome Measures

Name	Time	Method
Pathological Effect R0 resection rate Completion rate of each modality(Neoadjuvant chemotherapy, Operation and Adjuvant chemotherapy) Overall survival(OS) Disease Free survival(DFS) OS in patients with R0 resection DFS in patients with R0 resection Transition rate to Operation local recurrence rate(per Operated population) Safety Pattern of first recurrence