Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Phase 2

Recruiting

• Conditions: Rectum Cancer
• Interventions: Drug: mFolfox6; Drug: mFOLFIRINOX

• Registration Number: NCT06812728
• Lead Sponsor: Menoufia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2025-01-25
• Status Verified: 2025-02
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19
• Primary Completion: 2027-01-25
• Study Completion: 2027-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (mFolfox6)	mFolfox6	Chemotherapy (mFolfox6) then radiochemotherapy
Arm B (mFOLFIRINOX)	mFOLFIRINOX	Chemotherapy (mFOLFIRINOX) then radiochemotherapy

Primary Outcome Measures

Name	Time	Method
Complete clinical response rate	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Toxicity of chemotherapy	6 months	Common Terminology Criteria for Adverse Events (CTCAE) v 5
complete pathological response rectal cancer	6 months	the absence of malignant cells on the specimen of rectal resection in patients who were previously treated with neoadjuvant CRT.
disease-free survival	3 years	Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death
Overall survival	5 years	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.

Trial Locations

Locations (1)

Medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt