Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Menoufia University

Status and phase: Enrolling; Phase 2

Conditions: Rectum Cancer

Treatments: Drug: mFOLFIRINOX; Drug: mFolfox6

Study type: Interventional

Funder types: Other

Identifiers

NCT06812728

R2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven rectal adenocarcinoma.
2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
3. Resectable tumor, or considered as potentially resectable after CRT.
4. No distant metastases.
5. Patient eligible for surgery
6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
7. No heart failure or coronary heart disease symptoms (even controlled).
8. No peripheral neuropathy > grade 1.
9. No prior radiotherapy of the pelvis for any reason and no previous CT
10. No major comorbidity that may preclude the delivery of treatment
11. Adequate contraception in fertile patients.
12. Adequate hematologic function.

13 Adequate hepatic function.

14. Signed written informed consent.

Exclusion criteria

1. Metastatic disease
2. 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
3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
4. Medical history of angina pectoris or myocardial infarction
5. Other concomitant cancer.
6. Pregnant or breast-feeding woman.
7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm A (mFolfox6)

Active Comparator group

Description:

Chemotherapy (mFolfox6) then radiochemotherapy

Treatment:

Drug: mFolfox6

Arm B (mFOLFIRINOX)

Experimental group

Description:

Chemotherapy (mFOLFIRINOX) then radiochemotherapy

Treatment:

Drug: mFOLFIRINOX