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OPRA: Difference between revisions
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==Design== | ==Design== | ||
* Phase II | * Phase II, randomized, multicenter trial | ||
* N=324 patients with stage II or III rectal adenocarcinoma | * N=324 patients with stage II or III rectal adenocarcinoma | ||
* Setting: 18 institutions in the United States | * Setting: 18 institutions in the United States | ||
* Enrollment: 2014-2020 | * Enrollment: 2014-2020 | ||
* Follow-up: Median 3 years | * Follow-up: Median 3 years | ||
* Primary endpoint: 3-year | * Primary endpoint: 3-year DFS | ||
* Secondary endpoints: TME-free survival, adverse events, and local/distant recurrence rates | * Secondary endpoints: TME-free survival, adverse events, and local/distant recurrence rates | ||
* Analysis: Intention-to-treat, Kaplan-Meier survival estimates, and multivariable Cox regression | * Analysis: Intention-to-treat, Kaplan-Meier survival estimates, and multivariable Cox regression | ||
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===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
* Age >18 years | * Age >18 years | ||
* | * Stage II (T3-4, N0) or III (any T, N1-2) rectal adenocarcinoma | ||
* No distant metastasis or prior pelvic irradiation | * No distant metastasis or prior pelvic irradiation | ||
* Adequate organ function and ECOG performance status ≤1 | * Adequate organ function and ECOG performance status ≤1 | ||
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===Exclusion Criteria=== | ===Exclusion Criteria=== | ||
* Recurrent rectal cancer | * Recurrent rectal cancer | ||
* Incomplete staging or prior treatments disrupting TNT protocols | * Incomplete staging or prior treatments disrupting TNT protocols | ||
* History of other malignancies within 5 years | * History of other malignancies within 5 years | ||
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* **CRT-CNCT group**: Chemoradiotherapy followed by consolidation chemotherapy (mFOLFOX6 or CAPEOX) | * **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 | * Restaging with MRI, endoscopy, and physical exam to assess response | ||
==Outcomes== | ==Outcomes== | ||
===Primary Outcome=== | ===Primary Outcome=== | ||
* 3-year DFS: 76% (both groups, p=NS) | * 3-year DFS: 76% (both groups, p=NS) | ||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||