Multicenter Clinical Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with Metformin

JRCT ID: jRCTs011200001

Registered date:10/07/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 05/08/2020
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Neoadjuvant chemoradiotherapy (capecitabine and 50.4 Gy radiation) with metformin for rectal cancer in patients without diabetes mellitus

Outcome(s)

Primary Outcome

Dose-limiting toxicity (Phase I)
Pathological complete response rate considering the central pathological diagnosis (Phase II)

Secondary Outcome

Pathological complete response rate considering the domestic pathological diagnosis
Objective response rate
R0 resection rate
Disease-free survival
Recurrence site
Overall survival
Completion rate of the protocol treatment
Adverse events
Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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
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

Related Information

• Primary Sponsor: Taketomi Akinobu