Clinical trial · Interventional
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer: An Internal Pilot Study
NCT03053544CI-TRIAL-00040890completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a phase II, single arm, controlled, open label internal pilot.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasm Carcinoma in Situ Adenocarcinoma | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1 to 2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) rate
- timeFrame
- 1 year
- description
- The primary outcome is to evaluate the use of metformin to improve pathological complete response (pCR) rates in non-diabetic participants undergoing standard of care neoadjuvant CRT for rectal cancer. The primary outcome will be measured by the pathological complete response rate after completion of the study treatment.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Plan for care inclusive of: i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (TME) 2. Histologically confirmed adenocarcinoma of the rectum 3. At least one of the following: i. T3 or T4 lesions ii. T2 lesions ≤ 1 mm to the mesorectal fascia iii. Node positive rectal tumor 4. ECOG performance status of 0 or 1 5. Provide written informed consent 6. Female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of CRT. Contraception will not be required to be continued during or after CRT as this treatment renders participants infertile. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge. Exclusion Criteria: 1. Diagnosis of diabetes 2. Current use of metformin 3. Prior pelvic radiation 4. Life expectancy \< 6 months. 5. Active infection 6. Creatinine \> 1.5X ULN, within 1 month prior to baseline 7. AST, ALT \> 2.5X ULN, within 1 month prior to baseline 8. Bilirubin \> 1.5 ULN, within 1 month prior to baseline 9. Pregnant or breastfeeding women
References
Publications (0)
Data not yet available
No reference posted for this study.