A Phase 2 interventional study of mFOLFIRINOX and mFolfox6 in Rectum Cancer, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Menoufia University · Phase 2, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
13 Adequate hepatic function.
Exclusion Criteria:
Chemotherapy (mFolfox6) then radiochemotherapy
Drug: mFolfox6
Chemotherapy (mFOLFIRINOX) then radiochemotherapy
Drug: mFOLFIRINOX
Neoadjuvant chemotherapy
Neoadjuvant chemotherapy
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.
Time frame: 6 months
Toxicity of chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v 5
Time frame: 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.
Time frame: 6 months
disease-free survival
Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death
Time frame: 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.
Time frame: 5 years
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Menoufia University