SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \[pCR\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old, female and male;
Pathological confirmed adenocarcinoma;
The distance from anal verge ≤ 10 cm;
MSI/MMR status: MSS/pMMR;
Disqualifiers
Pregnancy or breast-feeding women;
Known history of other malignancies within 5 years;
Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
Trial design
Design model
Parallel
Treatments tested in this trial
short-course radiaotherapy
Radiationshort-course radiaotherapy (25Gy/5Fx)
long-course chemoradiaothearpy
Radiationlong-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine 825mg/m2 bid d1-5 qw)
Capecitabine
DrugCapecitabine: 1000mg/m2 bid d1-14 q3w
Oxaliplatin
DrugOxaliplatin 130mg/m2 d1 q3w
PD-1 inhibitor
DrugSerplulimab 300mg d1 q3w
Treatment groups
612 Participants
are divided into 2 treatment groupsGroup A: TNT groupOther 3 interventions
Group B: iTNT groupExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
3 year event-free survival rate
Rate of 3 year event free survival
Time frame
From date of randomization until the date of first documented early local failure, disease progression during neoadjuvant therapy, pelvic recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.Secondary outcomes
1
Complete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
Time frame
1 month after the surgery or the decision of W&W2
3 year organ preservation rate
3 year organ preservation rate
Time frame
From date of randomization until the resection of rectum or anus, assessed up to 36 months.3
3 year disease free survival rate
Rate of 3 year disease free survival
Time frame
From date of randomization until the date of first documented recurrence and metastasis after the completion of treatment or death from any cause, whichever came first, assessed up to 36 months.4
3 year local recurrence free survival rate
Rate of 3 year local recurrence free survival
Time frame
From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.Sponsors and contacts
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Source ClinicalTrials.gov
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