JPRN-jRCTs011200001
Active, not recruiting
Phase 1
Multicenter Phase I/II Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with Metformin - RC-COMET Study
Taketomi Akinobu0 sites64 target enrollmentJuly 10, 2020
ConditionsRectal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rectal cancer
- Sponsor
- Taketomi Akinobu
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Rectal adenocarcinoma on biopsy of the primary tumor
- •2\. Lower edge of the rectal cancer is less than 15 cm from the anal verge before chemoradiotherapy
- •3\. Clinical T3\-4NanyM0 before chemoradiotherapy
- •4\. Resectable rectal cancer before chemoradiotherapy
- •5\. Aged between 20 and 75 years
- •6\. Eastern Cooperative Oncology Group Performance Status score of 0
- •7\. Meeting each of the following parameters: white blood cell count: 3,000/mm3 or higher; neutrophil count: 2,000/mm3 or higher; hemoglobin level: 9\.0 g/dL or higher; platelet count: 100,000/mm3 or higher; total bilirubin level: less than 2\.0 mg/dL; and the ratio of aspartate aminotransferase and alanine aminotransferase: less than 3 times the normal upper value
- •8\. Written informed consent
Exclusion Criteria
- •1\. Multiple primary cancers
- •2\. Recurrent rectal cancer
- •3\. History of chemoradiotherapy to the pelvis
- •4\. Inflammatory bowel disease
- •5\. Pulmonary fibrosis or interstitial pneumonia
- •6\. Myocardial infarction or severe heart failure
- •7\. Renal failure (creatinine level of \>1\.4 mg/dL in men and \>1\.3 mg/dL in women or a creatinine clearance rate of \<60 mL/min)
- •8\. Diabetes mellitus (glycated hemoglobin \>6\.5% or drug treatment)
- •9\. Uncontrolled systemic infection
- •10\. Pregnancy or lactation
Outcomes
Primary Outcomes
Not specified
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