Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial
Abstract Background For obstructive colon cancer, many studies have been conducted on the use of self-expandable metallic stents (SEMS) as a bridge to surgery (BTS). However, there are currently no available prospective data on the impact of bridging period and there is a lack of research on the eff...
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BMC
2025-02-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-025-13588-0 |
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| author | Bong-Hyeon Kye Ji-Hoon Kim Hyung-Jin Kim Yoon-Suk Lee In-Kyu Lee Won Kyung Kang Hyeon-Min Cho Jong-Kyung Park Chang-Hyeok Ahn Jae-Im Lee Seong-Taek Oh Byung Jo Choi |
| author_facet | Bong-Hyeon Kye Ji-Hoon Kim Hyung-Jin Kim Yoon-Suk Lee In-Kyu Lee Won Kyung Kang Hyeon-Min Cho Jong-Kyung Park Chang-Hyeok Ahn Jae-Im Lee Seong-Taek Oh Byung Jo Choi |
| author_sort | Bong-Hyeon Kye |
| collection | DOAJ |
| description | Abstract Background For obstructive colon cancer, many studies have been conducted on the use of self-expandable metallic stents (SEMS) as a bridge to surgery (BTS). However, there are currently no available prospective data on the impact of bridging period and there is a lack of research on the effects of neoadjuvant chemotherapy during the bridging period. Objectives Patients who undergo successful SEMS placement for obstructive left-sided colon adenocarcinoma without metastases will be eligible for this study. Design This study is a multicenter, non-inferiority, randomized (1:1), open-label, controlled trial. Methods & analysis The patients assigned to the control group will undergo curative surgery within two weeks after successful SEMS placement. The patients assigned to the experimental group will undergo three cycles of neoadjuvant FOLFOX chemotherapy within two weeks after successful SEMS placement. Curative surgery will be performed within four weeks of the last administration of neoadjuvant FOLFOX. Circulating tumor DNA (ctDNA) will be collected at specific time points. Discussion The optimal time interval for SEMS placement as a BTS can significantly impact long-term oncologic outcomes. In this study, our goal is to identify the optimal time interval for SEMS placement as a BTS. Recently, there has been interest in applying neoadjuvant chemotherapy for locally advanced colon cancer. In the context of early treatment for tumor dissemination following SEMS placement, neoadjuvant chemotherapy may be beneficial for delayed surgery after SEMS placement as a BTS. The results of this trial will be an important reference for the application of neoadjuvant chemotherapy in locally advanced colon cancer. Additionally, researchers will investigate whether ctDNA can serve as a reliable indicator to guide decisions about the timing and type of subsequent treatment. Based on the results of this trial, a patient-tailored treatment strategy can be developed for obstructive colon cancer. Registration This study is registered on ClinicalTrials.gov Identifier: NCT04889820, registered on May 17, 2021 in clinicaltrials.gov; Protocol ID: XC21MIDI0004. |
| format | Article |
| id | doaj-art-81c267112d4a4cbdaba3bf2affcf7759 |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj-art-81c267112d4a4cbdaba3bf2affcf77592025-02-09T12:41:23ZengBMCBMC Cancer1471-24072025-02-012511910.1186/s12885-025-13588-0Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trialBong-Hyeon Kye0Ji-Hoon Kim1Hyung-Jin Kim2Yoon-Suk Lee3In-Kyu Lee4Won Kyung Kang5Hyeon-Min Cho6Jong-Kyung Park7Chang-Hyeok Ahn8Jae-Im Lee9Seong-Taek Oh10Byung Jo Choi11Department of Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Surgery, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaAbstract Background For obstructive colon cancer, many studies have been conducted on the use of self-expandable metallic stents (SEMS) as a bridge to surgery (BTS). However, there are currently no available prospective data on the impact of bridging period and there is a lack of research on the effects of neoadjuvant chemotherapy during the bridging period. Objectives Patients who undergo successful SEMS placement for obstructive left-sided colon adenocarcinoma without metastases will be eligible for this study. Design This study is a multicenter, non-inferiority, randomized (1:1), open-label, controlled trial. Methods & analysis The patients assigned to the control group will undergo curative surgery within two weeks after successful SEMS placement. The patients assigned to the experimental group will undergo three cycles of neoadjuvant FOLFOX chemotherapy within two weeks after successful SEMS placement. Curative surgery will be performed within four weeks of the last administration of neoadjuvant FOLFOX. Circulating tumor DNA (ctDNA) will be collected at specific time points. Discussion The optimal time interval for SEMS placement as a BTS can significantly impact long-term oncologic outcomes. In this study, our goal is to identify the optimal time interval for SEMS placement as a BTS. Recently, there has been interest in applying neoadjuvant chemotherapy for locally advanced colon cancer. In the context of early treatment for tumor dissemination following SEMS placement, neoadjuvant chemotherapy may be beneficial for delayed surgery after SEMS placement as a BTS. The results of this trial will be an important reference for the application of neoadjuvant chemotherapy in locally advanced colon cancer. Additionally, researchers will investigate whether ctDNA can serve as a reliable indicator to guide decisions about the timing and type of subsequent treatment. Based on the results of this trial, a patient-tailored treatment strategy can be developed for obstructive colon cancer. Registration This study is registered on ClinicalTrials.gov Identifier: NCT04889820, registered on May 17, 2021 in clinicaltrials.gov; Protocol ID: XC21MIDI0004.https://doi.org/10.1186/s12885-025-13588-0Colon cancerColon obstructionSelf expandable metallic stentNeoadjuvant chemotherapyBridge to surgery |
| spellingShingle | Bong-Hyeon Kye Ji-Hoon Kim Hyung-Jin Kim Yoon-Suk Lee In-Kyu Lee Won Kyung Kang Hyeon-Min Cho Jong-Kyung Park Chang-Hyeok Ahn Jae-Im Lee Seong-Taek Oh Byung Jo Choi Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial BMC Cancer Colon cancer Colon obstruction Self expandable metallic stent Neoadjuvant chemotherapy Bridge to surgery |
| title | Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial |
| title_full | Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial |
| title_fullStr | Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial |
| title_full_unstemmed | Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial |
| title_short | Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial |
| title_sort | oncologic outcomes of neoadjuvant chemotherapy for obstructive colon cancer after stent decompression outstand trial a study protocol of multicenter non inferiority randomized controlled trial |
| topic | Colon cancer Colon obstruction Self expandable metallic stent Neoadjuvant chemotherapy Bridge to surgery |
| url | https://doi.org/10.1186/s12885-025-13588-0 |
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