Status:
UNKNOWN
RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).
Lead Sponsor:
Clinical Research Support Center Kyush
Conditions:
Rectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02280070
Start Date
September 1 2013
End Date
August 1 2020
Last Update
October 31 2014
Active Locations (2)
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1
Kyushu University Hospital
Fukuoka, Japan, 812-8582
2
Kurume University Hospital
Kurume, Japan, 830-0011