Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2011
Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT₃NxM0, low rectal cancer: a phase II study.
Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01434147 (Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine), which is not on this map. Cited by 14 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)
Who cites it
14 citing papers in PubMed, 23 citations in OpenAlex.
- Intensified preoperative chemoradiation by adding oxaliplatin in locally advanced, primary operable (cT3NxM0) rectal cancer : Impact on long-term outcome. Results of the phase II TAKO 05/ABCSG R‑02 trial.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018Trial
- Phase II trial of preoperative radiochemotherapy with concurrent bevacizumab, capecitabine and oxaliplatin in patients with locally advanced rectal cancer.Radiation oncology (London, England) · 2013Trial
- Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin.PloS one · 2013Trial
- Re-irradiation combined with capecitabine in locally recurrent squamous cell carcinoma of the head and neck. A prospective phase II trial.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012Trial
- Neoadjuvant capecitabine, radiotherapy, and bevacizumab (CRAB) in locally advanced rectal cancer: results of an open-label phase II study.Radiation oncology (London, England) · 2011Trial
- Prediction of survival after neoadjuvant therapy in locally advanced rectal cancer - a retrospective analysis.Frontiers in oncology · 2024Article
- The potential predictive value of tumor budding for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018Article
- Long-term surveillance of locally advanced rectal cancer patients with neoadjuvant chemoradiation and aggressive surgical treatment of recurrent disease: a consecutive single-centre experience.International journal of colorectal disease · 2015Article
- [Impact of anastomotic leakage on long-term survival in mid-to-low rectal cancer].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2015Article
- Assessment of response to neoadjuvant radiochemotherapy with F-18 FLT and F-18 FDG PET/CT in patients with rectal cancer.Annals of nuclear medicine · 2015Article
- Neoadjuvant-intensified treatment for rectal cancer: time to change?World journal of gastroenterology · 2013Article
- Clinical outcome of rectal cancer in patients ≥ 80 years treated in southern France (PACA region) between 2002 and 2005.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012Article
- Simultaneous neoadjuvant radiochemotherapy with capecitabine and oxaliplatin for locally advanced rectal cancer. Treatment outcome outside clinical trials.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012Article
- Radiotherapy in elderly patients with inoperable esophageal cancer. Is there a benefit?Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012Article
Corrections and comments
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Authors and funding
16 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn patients with locally advanced rectal cancer (LARC), preoperative chemoradiation is known to improve local control, and down-staging of the tumor serves as a surrogate for survival. Intensification of the systemic therapy may lead to higher downstaging rates and, thus, enhance survival. This phase II study investigated the efficacy and safety of preoperative capecitabine and oxaliplatin in combination with radiotherapy. PATIENTS AND
methodsPatients with LARC of the mid and lower rectum, T₃NxM0 staged by MRI received radiotherapy (total dose 45 Gy) in combination with oral capecitabine (825 mg/m² twice a day on radiotherapy days; weeks 1-4) and oxaliplatin 50 mg/m² intravenously (days 1, 8, 15, and 22). Efficacy was evaluated as rate of tumor down-categorization at the T level.
resultsA total of 59 patients were enrolled (19 women, 40 men; median age of 61 years) and all were evaluable for efficacy and toxicity. Down-categorization at the T level was observed in 53% with pathological complete response in 6 patients (10%). Actual total radiotherapy, oxaliplatin and capecitabine doses received were 97%, 90%, and 93% of the protocol-specified preplanned doses, respectively. Grade 3/4 toxicity was observed in 15 patients (25%). The most frequent was diarrhea (12%).
conclusionsPreoperative chemoradiation with capecitabine and oxaliplatin is feasible in patients with MRI-proven cT₃ LARC. The only clinically relevant toxicity was diarrhea. Overall, efficacy of the multimodality treatment was good, but not markedly exceeding that of 5-FU- or capecitabine-based chemoradiation approaches.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.