TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center Hospital East
About this trial
This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
Eligibility criteria
Qualifiers
The content of this research was fully explained, and written informed consent was obtained from the subject.
Histologically confirmed rectal adenocarcinoma.
Radical resection is clinically possible without any distant metastases on imaging studies.
Age of 18 years or older on the date of consent acquisition.
Disqualifiers
Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.
Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).
Colonic stent in place.
Contraindications for MRI such as cardiac pacemakers.
Trial design
Treatments tested in this trial
- SCRT
- CAPOX
- CAPOXIRI
Treatment groups
608 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Cancer Center Hospital East
Lead sponsor
Japan Agency for Medical Research and Development
Collaborator
Source ClinicalTrials.gov