Rectum CancerPhase 2NCT06812728
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
A Phase 2 study testing mFOLFIRINOX and mFolfox6 in people with Rectum Cancer, run by Menoufia University at 1 site in Egypt.
Trial summary
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- mFOLFIRINOX and mFolfox6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2025to 25 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven rectal adenocarcinoma.
- Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
- Resectable tumor, or considered as potentially resectable after CRT.
- No distant metastases.
- Patient eligible for surgery
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
Show all 14Show fewer
- No heart failure or coronary heart disease symptoms (even controlled).
- No peripheral neuropathy > grade 1.
- No prior radiotherapy of the pelvis for any reason and no previous CT
- No major comorbidity that may preclude the delivery of treatment
- Adequate contraception in fertile patients.
- Adequate hematologic function.
- 13 Adequate hepatic function.
- 14. Signed written informed consent.
Who cannot join
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
- Other concomitant cancer.
- Pregnant or breast-feeding woman.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Medicine
Shibīn al Kawm, Menoufia, 32511
faculty of medicine, 0482330325 ext. +20, medcine@menofia.edu.eg
0482224819 ext. +20
About this study
Official title: Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.
Read the detailed description
This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.
- Conditions
- Rectum Cancer
- Being tested
- mFOLFIRINOX, mFolfox6
- Keywords
- Neoadjuvant, mFOLFIRINOX, TNT, Watch and wait approach, Complete clinical response, Sphincter sparing
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOXDrug
Neoadjuvant chemotherapy
mFolfox6Drug
Neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A (mFolfox6) | Active comparator | Chemotherapy (mFolfox6) then radiochemotherapy Receives: Drug: mFolfox6 |
| Arm B (mFOLFIRINOX) | Experimental | Chemotherapy (mFOLFIRINOX) then radiochemotherapy Receives: Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response rate
an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy.
Measured: 6 months
Secondary outcomes (4)
Toxicity of chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v 5
Measured: 6 months
complete pathological response rectal cancer
the absence of malignant cells on the specimen of rectal resection in patients who were previously treated with neoadjuvant CRT.
Measured: 6 months
disease-free survival
Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death
Measured: 3 years
Overall survival
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start25 Jan 2025
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yostena nagy kamel mekhail, Menoufia University
- Investigators
- Yostena Mekhail, MD,PhD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812728
- Sponsor's protocol ID
- R2025
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
- ClinicalTrials.gov ID
- NCT06812728
- Acronym / sponsor ID
- R2025
- Conditions
- Rectum Cancer
- Keywords
- Neoadjuvant, mFOLFIRINOX, TNT, Watch and wait approach, Complete clinical response, Sphincter sparing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (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.
A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.
Detailed description
This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (mFolfox6) | Active comparator | Drug: mFolfox6Chemotherapy (mFolfox6) then radiochemotherapy |
| Arm B (mFOLFIRINOX) | Experimental | Drug: mFOLFIRINOXChemotherapy (mFOLFIRINOX) then radiochemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven rectal adenocarcinoma.
- Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
- Resectable tumor, or considered as potentially resectable after CRT.
- No distant metastases.
- Patient eligible for surgery
Key exclusion criteria (7 listed)
- Metastatic disease
- Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina pectoris or myocardial infarction
- Other concomitant cancer.
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 |
|---|---|---|
| mFOLFIRINOXNeoadjuvant chemotherapy | Drug | Arm B (mFOLFIRINOX) |
| mFolfox6Neoadjuvant chemotherapy | Drug | Arm A (mFolfox6) |
Primary outcome
Complete clinical response rate
Time frame: 6 months
an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy.
4 secondary outcomes
Toxicity of chemotherapy
Time frame: 6 months
complete pathological response rectal cancer
Time frame: 6 months
disease-free survival
Time frame: 3 years
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
Yostena Mekhail, MD,PhD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFIRINOX and mFolfox6 in people with Rectum Cancer, run by Menoufia University at 1 site 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 14 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E Morkos (00201061323285, yoyonagy7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical response 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?
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 19 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.