RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).

Launched by CLINICAL RESEARCH SUPPORT CENTER KYUSH · Oct 29, 2014

Keywords

ClinConnect Summary

1. Patient registration procedure

If it is confirmed that the subject meets the inclusion criteria and correspondent none of the exclusion criteria, the subject is registered by using CReS Kyushu registration/allocation system (CK-RAS). The registration with CK-RAS is available for 24hr (URL: https://reg.cres-kyushu.or.jp/qmin/login/) and needs for individual ID and password.

2. Quality management

1. Monitoring

A central monitoring or in-site monitoring are carried out based on the data from case report form (CRF) collecting at data coordinating center. In principle, an on-site monit...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Patients who are judged to be suitable for receiving this protocol therapy by physician
• • Distal border of tumor is located under the peritoneal reflection
• • Histologically confirmed rectal adenocarcinoma
• • Previously untreated rectal cancer
• • Within 28 days before registration, the tumor is considered by the surgeon to be amenable to curative resection \[T category: cSS and cSE, cSI, cA, cAI. N category: cN0-2 and cN3(#253 lymph node)\]
• • Within 28 days before registration, there is no evidence of distant metastasis by contrast-enhanced CT
• • \>= 20 years old
• • PS (ECOG) 0-1
• • Be able to take oral drugs
• • Required baseline laboratory parameters (within 14 days before registration): WBC \>= 3000 ,\<12000/mm3, Neu \>= 1,500/ mm3, Hb \>= 9.0g/dl, Plt \>= 100,000/ mm3, T-Bil \<= 2.0mg/dl, AST,ALT \<= 100U/L, Cre \<1.5mg/dl, Ccr \>= 60mL/min
• • Considered to survive for more than 3 months
• Exclusion Criteria:
• • History of serious drug hypersensitivity or a history of drug allergy
• • Pregnant or lactating woman and man who hope for Partner's pregnant
• • Active infection(over 38 degree)
• • Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension)
• • Clinically significant abnormal electrocardiogram or heart disease
• • Serious diarrhea
• • Pleural effusion, peritoneal fluid that needs treatment
• • Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
• • Hemorrhagic diathesis, coagulation disorder
• • Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
• • Patients who need flucytosine, phenytoin or warfarin potassium
• • Requiring steroid drug
• • Patients with contraindication to therapy
• • History of allergy to contrast material
• • Serious stricture (exclude the patients who are put in stoma)
• • Positive for HBs antigen and HCV antibody
• • Not appropriate for the study at the physician's assessment