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Cited by 549

The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.

Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12

Open access
Fokas, Emmanouil, Allgäuer, Michael, Polat, Bülent, Klautke, Gunther, Grabenbauer, Gerhard G., Fietkau, Rainer, Kuhnt, Thomas, Staib, Ludger, Brunner, Thomas, Grosu, Anca-Ligia, Schmiegel, Wolff, Jacobasch, Lutz, Weitz, Jürgen, Folprecht, Gunnar, Schlenska-Lange, Anke, Flentje, Michael, Germer, Christoph-Thomas, Grützmann, Robert, Schwarzbach, Matthias, Paolucci, Vittorio, Bechstein, Wolf O., Friede, Tim, Ghadimi, Michael, Hofheinz, Ralf-Dieter, Rödel, Claus, on behalf of the German Rectal Cancer Study Group·2019·Journal of Clinical Oncology

Abstract

PURPOSE: Total neoadjuvant therapy is a new paradigm for rectal cancer treatment. Optimal scheduling of preoperative chemoradiotherapy (CRT) and chemotherapy remains to be established. PATIENTS AND METHODS: We conducted a multicenter, randomized, phase II trial using a pick-the-winner design on the basis of the hypothesis of an increased pathologic complete response (pCR) of 25% after total neoadjuvant therapy compared with standard 15% after preoperative CRT. Patients with stage II or III rectal cancer were assigned to group A for induction chemotherapy using three cycles of fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT (50.4 Gy) or to group B for consolidation chemotherapy after CRT. Secondary end points included toxicity, compliance, and surgical morbidity. RESULTS: Of the 311 patients enrolled, 306 patients were evaluable (156 in group A and 150 in group B). CRT-related grade 3 or 4 toxicity was lower (37% v 27%) and compliance with CRT higher in group B (91%, 78%, and 76% v 97%, 87%, and 93% received full-dose radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin in groups A and B, respectively); 92% versus 85% completed all induction/consolidation chemotherapy cycles, respectively. The longer interval between completion of CRT and surgery in group B (median 90 v 45 days in group A) did not increase surgical morbidity. A pCR in the intention-to-treat population was achieved in 17% in group A and in 25% in group B. Thus, only group B ( P < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis. CONCLUSION: Up-front CRT followed by chemotherapy resulted in better compliance with CRT but worse compliance with chemotherapy compared with group A. Long-term follow-up will assess whether improved pCR in group B translates to better oncologic outcome.

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Metadata

Authors
Fokas, E., Allgäuer, M., Polat, B., Klautke, G., Grabenbauer, G. G., Fietkau, R., Kuhnt, T., Staib, L., Brunner, T., Grosu, A.-L., Schmiegel, W., Jacobasch, L., Weitz, J., Folprecht, G., Schlenska-Lange, A., Flentje, M., Germer, C.-T., Grützmann, R., Schwarzbach, M., Paolucci, V., Bechstein, W. O., Friede, T., Ghadimi, M., Hofheinz, R.-D., Rödel, C., & on behalf of the German Rectal Cancer Study Group
Venue
Journal of Clinical Oncology
Published
2019-12-01
Volume
37
Issue
34
Pages
3212-3222
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2947040388
Cited by
549
References
26
FWCI
22.13
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12. https://app.cochat.ai/papers/10.1200/jco.19.00308
The paper
Fokas, E., Allgäuer, M., Polat, B., Klautke, G., Grabenbauer, G. G., Fietkau, R., Kuhnt, T., Staib, L., Brunner, T., Grosu, A.-L., Schmiegel, W., Jacobasch, L., Weitz, J., Folprecht, G., Schlenska-Lange, A., Flentje, M., Germer, C.-T., Grützmann, R., Schwarzbach, M., . . . on behalf of the German Rectal Cancer Study Group. (2019). Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12. Journal of Clinical Oncology. https://doi.org/10.1200/jco.19.00308

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.