Neoadjuvant treatment for locally advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medicine
  Shibīn al Kawm, Menoufia, Egypt Recruiting

Study contacts

• Principal investigator: Yostena Mekhail, MD,PhD — Menoufia University
• Study coordinator: E Morkos
• Email: yoyonagy7@gmail.com
• Phone: 00201061323285

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.