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A German trial that tested whether chemotherapy should come before or after chemoradiotherapy. Afterwards gave more complete responses, which matters for keeping the rectum.
CAO/ARO/AIO-12 randomised 311 patients (306 evaluable) with locally advanced rectal cancer to chemoradiotherapy preceded by three cycles of FOLFOX (group A, induction) or followed by three cycles (group B, consolidation). Pathological complete response in the intention-to-treat population was 17 percent in group A and 25 percent in group B; only group B met the predefined statistical hypothesis. Compliance with chemoradiotherapy was better in group B and compliance with chemotherapy better in group A, and the longer interval to surgery in group B (median 90 against 45 days) did not increase surgical morbidity. The result is why consolidation chemotherapy, not induction, is the sequence used when organ preservation is the aim, the same conclusion OPRA reached for watch and wait.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
311 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete responseprimary | Induction chemotherapy then chemoradiotherapy | 156 | 17 percent | - | - | link |
| Chemoradiotherapy then consolidation chemotherapy | 150 | 25 percent |
Shares PROSPECT (Alliance N1048), PRODIGE 23, OPRA, Clinical complete response (cCR).
Shares CAO/ARO/AIO-94 (German Rectal Cancer Study), PRODIGE 23, OPRA, Chemoradiation (chemoradiotherapy, CRT).
Shares CAO/ARO/AIO-94 (German Rectal Cancer Study), PROSPECT (Alliance N1048), IMRT / IGRT (modern external beam), Rectal cancer.
Shares PRODIGE 23, Chemoradiation (chemoradiotherapy, CRT), Oxaliplatin, FOLFOX (5-FU, leucovorin, oxaliplatin).
Shares FOLFOX (5-FU, leucovorin, oxaliplatin), Fluorouracil (5-FU), IMRT / IGRT (modern external beam), Rectal cancer.
Shares CAO/ARO/AIO-94 (German Rectal Cancer Study), Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), Rectal cancer.
Shares Fluorouracil (5-FU), IMRT / IGRT (modern external beam), Rectal cancer, Cytotoxic chemotherapy.
Shares Fluorouracil (5-FU), IMRT / IGRT (modern external beam), Rectal cancer, Cytotoxic chemotherapy.