Clinical trial · Interventional
RP II Study of SOX vs mFOLFOX6 in Patients With Resectable Rectal Cancer (KSCC1301).
Randomized Phase II Study of SOX vs mFOLFOX6 as Neoadjuvant Chemotherapy in Patients With Resectable Rectal Cancer (KSCC1301).
NCT02280070CI-TRIAL-00015958unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Adverse event | Other | — | UNRESOLVED |
| Biomarker | Other | — | UNRESOLVED |
| BW and height | Other | — | UNRESOLVED |
| Contrasting CT | Radiation | — | UNRESOLVED |
| Creatinine clearance | Other | — | UNRESOLVED |
| Endoscopy | Other | — | UNRESOLVED |
| HBs antibody and HBc antibody | Other | — | UNRESOLVED |
| HBs antigen and HCV antibody | Other | — |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SOX (S-1 + L-OHP)
- description
- S-1 (80 mg/m2, p.o.) (day1-14）, L-OHP (130 mg/m2)(day 1): repeated every 3 weeks until 4 courses or meet discontinuation criteria. Medical history and physical examination, BW and height, performance status, laboratory test, creatinine clearance, biomarker, contrasting CT, adverse event, HBs antigen and HCV antibody, endoscopy, HBs antibody and HBc antibody
- interventionNames
- Other: Laboratory test
- Other: Medical history and physical examination
- Other: BW and height
- Other: Performance status
- Other: Creatinine clearance
- Other: Biomarker
- Radiation: Contrasting CT
- Other: Adverse event
- Other: HBs antigen and HCV antibody
- Other: Endoscopy
- Other: HBs antibody and HBc antibody
- Drug: S-1
- Drug: L-OHP (130mg/m2)
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.