Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
Recruiting now · Phase 2
Conditions studied: Rectum Cancer
In brief
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.
Key facts
- Study ID
- NCT06812728
- Run by
- Menoufia University
- People needed
- 100
- Starts
- 2025-01-25
- Expected to finish
- 2027-02-25
- Last updated by the study team
- 2025-02-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Signed written informed consent.
You may not qualify if…
- 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.
Where it is running
- Medicine — Shibīn al Kawm, Menoufia, Egypt (enrolling)
Full record on ClinicalTrials.gov
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