Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mFOLFIRINOX, mFolfox6.
- Who it may be relevant to
- Registry conditions: Rectum Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.
Overview
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.
Interventions
- Drug mFOLFIRINOX
Neoadjuvant chemotherapy - Drug mFolfox6
Neoadjuvant chemotherapy
Primary outcome measures
- Complete clinical response rate [Time frame: 6 months]
Secondary outcome measures (4)
- Toxicity of chemotherapy [Time frame: 6 months]
- complete pathological response rectal cancer [Time frame: 6 months]
- disease-free survival [Time frame: 3 years]
- Overall survival [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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.
13 Adequate hepatic function.
14\. Signed written informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Medicine — Shibīn al Kawm
Identifiers
NCT: NCT06812728 · R2025