Rectal Cancer PatientsPhase 2/3NCT06728982
Impact Of Metformin In Rectal Cancer Patients
A Phase 2/3 study testing Metformin in people with Rectal Cancer Patients, run by Minia University at 2 sites in Egypt.
Trial summary
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: 1. Histologically confirmed diagnosis of rectal adenocarcinoma. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2024to 15 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Age starting from 18 and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function (renal, hepatic, and hematological)
- Signed informed consent.
Who cannot join
- Metastatic disease.
- Contraindications to metformin.
- Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
- eGFR less than 30 mL/min.
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Minia Oncology Center
Minya, Egypt, 61512
Minia University Hospital
Minya, Egypt, 61512
About this study
Official title: Metformin Enhances Pathological Complete Response in Non-Diabetic Rectal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy: A Randomized Controlled Trial
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:
Read more
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Age starting from 18 and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function (renal, hepatic, and hematological)
- Signed informed consent.
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:
- beginning 1-2 weeks before standard CRT.
- during standard CRT.
- until 30 days after the end of standard CRT.
- Conditions
- Rectal Cancer Patients
- Being tested
- Metformin
- Keywords
- metformin, complete pathological response, rectal patient, neoadjuvant chemoradiotherapy
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
1000mg of metformin twice daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. beginning 1-2 weeks before standard CRT.
2. during standard CRT.
3. until 30 days after the end of standard CRT. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 May 2024
- Primary completion15 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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: 1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Awad, Minia University
- Investigators
- Omar M Awad, Bsc, Principal investigator, Deraya UniversityFatma M Mady, professor, Study chair, Minia UniversityMona A Saber, PhD, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728982
- Sponsor's protocol ID
- Metformin In Rectal Cancer
- Status last verified
- May 2025
- First submitted
- 29 Nov 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awad OM, Saber MA, Ali Sholkamy NH, Abdel-Azeez AM, Sadek EM, Mady FM. Metformin enhances the pathological response in nondiabetic patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: A randomized controlled trial. J Pharmacol Exp Ther. 2026 Jun 19;393(8):104970. doi: 10.1016/j.jpet.2026.104970. Online ahead of print.
PubMed 42456199
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Enhances Pathological Complete Response in Non-Diabetic Rectal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06728982
- Acronym / sponsor ID
- Metformin In Rectal Cancer
- Conditions
- Rectal Cancer Patients
- Keywords
- metformin, complete pathological response, rectal patient, neoadjuvant chemoradiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Age starting from 18 and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function (renal, hepatic, and hematological)
- Signed informed consent.
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:
- beginning 1-2 weeks before standard CRT.
- during standard CRT.
- until 30 days after the end of standard CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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: 1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Patients will receive standard chemoradiotherapy(CRT) |
| Group B (Metformin) | Active comparator | Drug: MetforminPatients will self-administer 1000mg of metformin twice daily by mouth: 1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Age starting from 18 and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function (renal, hepatic, and hematological)
- Signed informed consent.
Key exclusion criteria (5 listed)
- Metastatic disease.
- Contraindications to metformin.
- Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
- eGFR less than 30 mL/min.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin1000mg of metformin twice daily by mouth | Drug | Group B (Metformin) |
Primary outcome
Pathological Complete Response (pCR) rate
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 42456199Awad OM, Saber MA, Ali Sholkamy NH, Abdel-Azeez AM, Sadek EM, Mady FM. Metformin enhances the pathological response in nondiabetic patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: A randomized controlled trial. J Pharmacol Exp Ther. 2026 Jun 19;393(8):104970. doi: 10.1016/j.jpet.2026.104970. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar M Awad, Bsc principal investigator
Deraya University
Fatma M Mady, professor study chair
Minia University
Mona A Saber, PhD study director
Minia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin in people with Rectal Cancer Patients, run by Minia University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.