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| fulltexturl= https://ascopubs.org/doi/full/10.1200/JCO.22.00032 | | fulltexturl= https://ascopubs.org/doi/full/10.1200/JCO.22.00032 | ||
| pdfurl= https://ascopubs.org/doi/pdf/10.1200/JCO.22.00032 | | pdfurl= https://ascopubs.org/doi/pdf/10.1200/JCO.22.00032 | ||
| status= | | status=incomplete | ||
| statusUsableDate= | | statusUsableDate= | ||
| subspecialty= | | subspecialty= Oncology | ||
| otherSubspecialty1= | | otherSubspecialty1= | ||
| disease= Rectal Cancer | | disease= Rectal Cancer | ||
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| briefDesignDescription= Randomized trial comparing disease-free survival and organ preservation with two neoadjuvant therapy sequences in rectal cancer | | briefDesignDescription= Randomized trial comparing disease-free survival and organ preservation with two neoadjuvant therapy sequences in rectal cancer | ||
| briefResultsDescription= Organ preservation achieved in ~50% of patients with no detriment to disease-free survival | | briefResultsDescription= Organ preservation achieved in ~50% of patients with no detriment to disease-free survival | ||
| trainingLevel= | | trainingLevel=resident | ||
}} | }} | ||
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==Interventions== | ==Interventions== | ||
* | * '''INCT-CRT group''': Induction chemotherapy (mFOLFOX6 or CAPEOX) followed by chemoradiotherapy | ||
* | * '''CRT-CNCT group''': Chemoradiotherapy followed by consolidation chemotherapy (mFOLFOX6 or CAPEOX) | ||
* Radiotherapy: 4,500-5,600 cGy with concurrent capecitabine or infusional fluorouracil | * Radiotherapy: 4,500-5,600 cGy with concurrent capecitabine or infusional fluorouracil | ||
* Restaging with MRI, endoscopy, CT chest abdomen pelvis, and physical within 8 weeks of completing TNT to assess response | * Restaging with MRI, endoscopy, CT chest abdomen pelvis, and physical within 8 weeks of completing TNT to assess response | ||
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==Outcomes== | ==Outcomes== | ||
===Primary Outcome=== | ===Primary Outcome=== | ||
; 3-year disease-free survival | |||
: ''Disease-free survival defined as lack of locoregional regrowth, distant metastasis, new colorectal primary, or death from any cause'' | |||
: 76% (both groups, p=NS) | |||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||
; Organ preservation (TME-free survival) | |||
: 41% (64/158) for INCT-CRT vs. 53% (87/166) for CRT-CNCT, p=0.01 | |||
; Local recurrence-free survival | |||
: 94% (both groups) | |||
; Distant metastasis-free survival | |||
: 84% (132/158) for INCT-CRT vs. 82% (136/166) for CRT-CNCT | |||
===Adverse Events=== | ===Adverse Events=== | ||
; Grade ≥3 adverse events during TNT | |||
: 41% (64/158) for INCT-CRT vs. 34% (57/166) for CRT-CNCT | |||
==Criticisms== | ==Criticisms== | ||