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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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