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Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.
To be eligible for participation, patients must meet the following criteria:
Patients will be randomized into two groups:
Group A: Patients will receive standard chemoradiotherapy(CRT).
Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | Patients will receive standard chemoradiotherapy(CRT) | |
| Group B (Metformin) | Active Comparator | Patients will self-administer 1000mg of metformin twice daily by mouth:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 1000mg of metformin twice daily by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) rate | The Main outcome is to assess the use of metformin to improve pathological complete response (pCR) rates among non-diabetic participants undergoing standard neoadjuvant CRT for rectal cancer. The primary outcome will be measured by the pathological complete response rate after completion of the study treatment. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar M Awad, Bsc | Deraya University | Principal Investigator |
| Fatma M Mady, professor | Minia University | Study Chair |
| Mona A Saber, PhD | Minia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia Oncology Center | Minya | Egypt | 61512 | Egypt | ||
| Minia University Hospital |
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| ID | Term |
|---|---|
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Patients will be randomized into two groups:
Group A: Patients will receive standard chemoradiotherapy(CRT).
Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:
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| Minya |
| Egypt |
| 61512 |
| Egypt |