Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).

NCT02280070 Phase 2 UNKNOWN

To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.

Details

Lead sponsor	Clinical Research Support Center Kyush
Phase	Phase 2
Status	UNKNOWN
Enrolment	110
Start date	2013-09
Completion	2020-08

Conditions

• Rectal Cancer

Interventions

• Laboratory test
• Medical history and physical examination
• BW and height
• Performance status
• Creatinine clearance
• Biomarker
• Contrasting CT
• Adverse event
• HBs antigen and HCV antibody
• Endoscopy

Primary outcomes

• 3-years Disease Free Survival rate — 3 years from the enrollment
  The last analysis after the follow-up period is conducted. The disease-free survival ratio that assumed full analysis set (FAS) as a denominator is estimating by Kaplan-Meier method at 3 year, up to 5 years after the last subject enrollment.

Countries

Japan