RecruitingPhase 2NCT06812728

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.

Sponsor

Menoufia University

Enrollment

100 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

Rectum Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria14

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.
Adequate hepatic function.
\. Signed written informed consent.

Exclusion Criteria7

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.

Interventions

DRUGmFOLFIRINOX

Neoadjuvant chemotherapy

DRUGmFolfox6

Neoadjuvant chemotherapy

Locations(1)

Medicine

Shibīn al Kawm, Menoufia, Egypt

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NCT06812728

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