Multicenter Clinical Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with Metformi
- Conditions
- Rectal cancer
- Registration Number
- JPRN-jRCTs011200001
- Lead Sponsor
- Taketomi Akinobu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
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
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
11. Psychosis or mental symptoms that could make it difficult for patients to participate in the trial
12. Drug allergies to capecitabine and metformin
13. Patients not willing or able to follow the study protocol
14. Other inadequate conditions for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (Phase I)<br>Pathological complete response rate considering the central pathological diagnosis (Phase II)
- Secondary Outcome Measures
Name Time Method Pathological complete response rate considering the domestic pathological diagnosis<br>Objective response rate<br>R0 resection rate<br>Disease-free survival <br>Recurrence site<br>Overall survival<br>Completion rate of the protocol treatment<br>Adverse events<br>Postoperative complications