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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
mFOLFIRINOX
DrugNeoadjuvant chemotherapy
mFolfox6
DrugNeoadjuvant chemotherapy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Arm A (mFolfox6)Active comparator 1 intervention
Group B: Arm B (mFOLFIRINOX)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete clinical response rate
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.
Time frame
6 monthsSecondary outcomes
1
Toxicity of chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v 5
Time frame
6 months2
complete pathological response rectal cancer
the absence of malignant cells on the specimen of rectal resection in patients who were previously treated with neoadjuvant CRT.
Time frame
6 months3
disease-free survival
Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death
Time frame
3 years4
Overall survival
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov