JPRN-jRCTs021210076
Recruiting
Phase 2
Phase II study evaluating the efficacy of personalized treatment for locally advanced rectal cancer
Miura Takuya0 sites40 target enrollmentMarch 16, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rectal cancer
- Sponsor
- Miura Takuya
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically confirmed rectal adenocarcinoma.
- •2\) Tumor lower margin is located at rectum (RS, Ra, Rb, P).
- •3\) High\-resolution MRI scan is available and any of the following factors are present.
- •Lateral lymph node metastasis, positive CRM, cT4, positive EMVI.
- •4\) No distant metastasis.
- •5\) Eastern Cooperative Oncology Group performance status (PS) 0\-1\.
- •6\) Age at enrollment must be 20 years or older.
- •7\) Adequate hematological, hepatic, renal and metabolic function parameters.
- •8\) Written informed concent.
Exclusion Criteria
- •1\) Active multiple cancers (intraepithelial cancer is acceptable).
- •2\) Contraindications to MRI (pacemaker, cerebral artery clipping, etc.)
- •3\) Patients with myelosuppression (neutrophil count \<1,500/mm3, platelet count \<100,000/mm3\).
- •4\) Patients with severe renal impairment (Creatinine Clearance \<30mL/min).
- •5\) History of chemotherapy for the target disease.
- •6\) Prior radiation therapy in the pelvic region.
- •7\) Drug hypersensitivity to study medications.
- •8\) History of major surgery (implantable central venous reservoir, stoma construction is acceptable) within 28 days prior to enrollment.
- •9\) History of clinically serious cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment.
- •10\) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.).
Outcomes
Primary Outcomes
Not specified
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