Neoadjuvant treatment for locally advanced rectal cancer

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.

This study is testing a new chemotherapy treatment for people with locally advanced rectal cancer to see if it works better than the standard treatment before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Menoufia University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shibīn al Kawm, Menoufia)
• Trial ID: NCT06812728 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of a neoadjuvant chemotherapy regimen using mFOLFIRINOX combined with preoperative chemoradiotherapy in patients with locally advanced rectal cancer. The study compares this approach to the standard total neoadjuvant therapy (TNT) involving mFolfox6 and chemoradiotherapy. Participants will be randomly assigned to one of the two treatment arms to assess clinical response and potential for surgical resection. The trial aims to determine if the new regimen can improve outcomes for patients at risk of local recurrence.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically proven rectal adenocarcinoma at specific stages (cT3, cT4, or N positive) who are eligible for surgery and have no distant metastases.

Not a fit: Patients with metastatic disease or unresectable rectal cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and increased chances of surgical resection for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have shown promise with similar neoadjuvant approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

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.

Where this trial is running

Shibīn al Kawm, Menoufia

• Medicine — Shibīn al Kawm, Menoufia, Egypt (Recruiting)

Study contacts

• Principal investigator: Yostena Mekhail, MD,PhD — Menoufia University
• Study coordinator: E Morkos

Conditions Rectum Cancer; Neoadjuvant; mFOLFIRINOX; TNT; Watch and wait approach; Complete clinical response; Sphincter sparing