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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Research Support Center Kyush
• Treatments: Antibodies; Fluorouracil; Hepatitis C Antibodies; Immunoglobulins; Leucovorin; Oxaliplatin; Tegafur

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