NCT06812728RecruitingPhase 2
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 Feb 2025
- Start date
- 25 Jan 2025
- Primary completion date
- 25 Jan 2027
- Lead sponsor
- Menoufia University
- Diseases
- Colorectal cancer
- NCT number
- NCT06812728
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 25 Jan 2025 to the primary completion date, 25 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant cancer.
Other illness
- 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
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Other
- Pregnant or breast-feeding woman.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicine Coordinator of this site? Confirm its status | Shibīn al Kawm | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.