Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
ConditionRectum Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMenoufia University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- mFOLFIRINOX
- mFolfox6
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov