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==Design== | ==Design== | ||
* Phase II, randomized, multicenter trial | * Phase II, non-blinded, 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 disease free survival | ||
* 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 | * Clinical Stage II (T3-4, N0) or III (any T, N1-2) | ||
*Clinical staging for rectal adenocarcinoma by MRI rectal cancer protocol, CT chest abdomen pelvis, and colonoscopy | |||
* 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 | ||
* Distant metastasis | |||
* Prior pelvic radiation | |||
* 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, and physical | * Restaging with MRI, endoscopy, CT chest abdomen pelvis, and physical within 8 weeks of completing TNT to assess response | ||
**Patients with a complete or near complete response were offered watch and wait | |||
**Watch and wait protocol consisted digital rectal examination and flexible sigmoidoscopy every 4 months for the first 2 years from the time of assessment of response, and every 6 months for the following 3 years | |||
***Rectal MRI was performed every 6 months for the first 2 years and yearly for the following 3 years | |||
**Patients with an incomplete response were recommended for total mesorectal excision | |||
**Patients with lack of complete response or those with evidence of endoscopic regrowth were recommended for TME | |||
==Outcomes== | ==Outcomes== | ||
===Primary Outcome=== | ===Primary Outcome=== | ||
* 3-year DFS: 76% (both groups, p=NS) | * 3-year DFS: 76% (both groups, p=NS) | ||
**DFS defined as lack of locoregional regrowth, distant metastasis, new colorectal primary, or death from any cause | |||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||