KCT0004874
Recruiting
未知
A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Kyungpook National University Medical Center
- Enrollment
- 364
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. A male/female adult between ages 20 and 75
- •2\. Race : Asian
- •3\. Eastern Cooperative Oncology Group performance score 0\-2
- •4\. Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal verge in pelvis magnetic resonance imaging (MRI)]
- •5\. Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
- •6\. Locally advanced rectal cancer with one or more of the following factors based on pelvis MRI: cTanyN1\-2, cT3\-4N0, or presence of extramural vascular invasion
- •7\. It is not an exclusion criterion if the pelvis MRI shows findings such as pelvic lymph node metastasis, anal sphincter invasion, MRF (\+), and T4b. This will depend on the researcher’s discretion. MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b are not included in the exclusion criteria, which cases will be enrolled by the researcher’s discretion.
- •8\. Patients with appropriate organ (bone marrow, kidney, and liver) function Normal liver function (direct bilirubin\< 0\.4 mg/dL)
- •Normal renal function (glomerular filtration rate \> 50 mL/min by Wright or Cockroft formula)
- •Normal bone marrow function (whilte blood cell \> 3\.0 × 109/L, platelet\>100×109/l)
Exclusion Criteria
- •1\. Colon cancer or rectal cancer located above more than 10 cm from the anal verge
- •2\. Stage I rectal cancer (clinical stage cT1\-2N0\)
- •3\. Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1\)
- •4\. Familial adenomatous polyposis
- •5\. Hereditary nonpolyposis colorectal cancer
- •6\. History of chemotherapy or radiotherapy within 6 months
- •7\. History of colorectal cancer or other type of malignancy within 5 years
- •8\. Currently under treatment or malignant tumors (except for cured nonmelanoma skin cancer or in situ cervical cancer)
- •9\. Comorbidities that render it difficult to undergo chemotherapy or radiotherapy
- •10\. Bone marrow suppression with neutrophil count \< 2 x 109/L and/or platelet count \< 100 x 109/L prior to the first chemotherapy
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A multi-centre randomised controlled trial of pre-hospital administration of packed red blood cells and freeze-dried plasma to patients with low blood pressure after major injuries.EUCTR2015-001401-13-GBniversity Hospitals Birmingham NHS Foundation Trust490
Recruiting
Phase 2
A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode .Simple febrile seizureJPRN-UMIN000004291Tokyo Metropolitan Pediatric acute disease clinical research network90
Not yet recruiting
Not Applicable
A Prospective, Randomized, Multicenter Trial of Pregabalin and Celecoxib for Lumbar Spinal Stenosisumbar Spinal StenosisJPRN-UMIN000007419Department of Orthopedic Surgery Kobe University Graduate School of Medicine80
Not yet recruiting
Not Applicable
The protective versus conventional ventilation during laparoscopic surgery trialPost-operative pulmonary complicationsMajor laparoscopic surgeryAnaesthesiology - Other anaesthesiologySurgery - Other surgeryACTRN12622001235796Austin Health1,750
Completed
Phase 3
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)suicide attemptsJPRN-C000000444Health Labour Sciences Research Grant Research on Psychiatric and Neurological Diseases and Mental Health Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP)914