The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Phase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Adenocarcinoma (RTOG 9904): Quality of Combined Modality Therapy and Pathologic Response
Abstract
Purpose: Preoperative therapy for localized gastric cancer has considerable appeal. We hypothesized that, in a cooperative group setting, preoperative chemoradiotherapy would induce a 20% pathologic complete response (pathCR) rate. Combined-modality therapy quality, survival, and safety were secondary end points. Patients and Methods: Patients with localized gastric adenocarcinoma were eligible. A negative laparoscopic evaluation was required. Patients received two cycles of induction fluorouracil, leucovorin, and cisplatin followed by concurrent radiation and chemotherapy (infusional fluorouracil and weekly paclitaxel). Resection was attempted 5 to 6 weeks after chemoradiotherapy was completed. Quality of therapy was assessed with other end points. Results: Twenty institutions participated. Forty-nine patients were entered and 43 were assessable (12% stage IB; 37% stage II; and 52% stage III). The pathCR and R0 resection rates were 26% and 77%, respectively. At 1 year, more patients with pathCR (82%) are living than those with less than pathCR (69%). Grade 4 toxicity occurred in 21% of patients. Chemotherapy, radiotherapy, and surgery per protocol (including acceptable variations) occurred in 98%, 44%, and 63% of patients, respectively. A D2 dissection was performed in 50% of patients. Of 18 major radiotherapy variations, 17 were due to the lack of inclusion of the L3-4 vertebral interphase as prespecified. Conclusion: For localized gastric cancer, preoperative chemoradiotherapy strategy achieved a pathCR rate of more than 20% in a cooperative group setting. The quality of surgery improved (50% with D2 dissection) possibly because surgery was part of this trial. With some refinements, this preoperative chemoradiotherapy strategy is poised for a randomized comparison with postoperative adjuvant chemoradiotherapy in patients with gastric cancer.
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Cites
Optimal two-stage designs for phase II clinical trials.
Simon, R. (1989) · Controlled Clinical Trials · doi:10.1016/0197-2456(89)90015-9 · Cited by 3,636
Cited by
Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Okines, A., Verheij, M., Allum, W., Cunningham, D., & Cervantes, A. (2010) · Annals of Oncology · doi:10.1093/annonc/mdq164 · Cited by 1,300
Wang, F., Zhang, X., Li, Y., Tang, L., Qu, X., Ying, J., Zhang, J., Sun, L., Lin, R., Qiu, H., et al. (2021) · Cancer Communications · doi:10.1002/cac2.12193 · Cited by 624
Wang, F., Zhang, X., Tang, L., Wu, Q., Cai, M., Li, Y., Qu, X., Qiu, H., Zhang, Y., Ying, J., et al. (2024) · Cancer Communications · doi:10.1002/cac2.12516 · Cited by 428
Metadata
- Authors
- Ajani, J. A., Winter, K., Okawara, G. S., Donohue, J. H., Pisters, P. W. T., Crane, C. H., Greskovich, J. F., Anne, P. R., Bradley, J. D., Willett, C., & Rich, T. A.
- Venue
- Journal of Clinical Oncology
- Published
- 2006-08-20
- Volume
- 24
- Issue
- 24
- Pages
- 3953-3958
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2149415769
- Cited by
- 385
- References
- 1
- FWCI
- 13.95
- Type
- journal article
- Language
- en
- Open access
- closed
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- Ajani, J. A., Winter, K., Okawara, G. S., Donohue, J. H., Pisters, P. W. T., Crane, C. H., Greskovich, J. F., Anne, P. R., Bradley, J. D., Willett, C., & Rich, T. A. (2006). Phase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Adenocarcinoma (RTOG 9904): Quality of Combined Modality Therapy and Pathologic Response. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2006.06.4840
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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.