Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol
BackgroundResults from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49% of patients with a squamous cell carcinoma (SCC) and 2...
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| Format: | Article |
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JMIR Publications
2015-06-01
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| Series: | JMIR Research Protocols |
| Online Access: | http://www.researchprotocols.org/2015/2/e79/ |
| _version_ | 1819273859758555136 |
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| author | Noordman, Bo Jan Shapiro, Joel Spaander, Manon CW Krishnadath, Kausilia K van Laarhoven, Hanneke WM van Berge Henegouwen, Mark I Nieuwenhuijzen, Grard AP van Hillegersberg, Richard Sosef, Meindert N Steyerberg, Ewout W Wijnhoven, Bas PL van Lanschot, J Jan B |
| author_facet | Noordman, Bo Jan Shapiro, Joel Spaander, Manon CW Krishnadath, Kausilia K van Laarhoven, Hanneke WM van Berge Henegouwen, Mark I Nieuwenhuijzen, Grard AP van Hillegersberg, Richard Sosef, Meindert N Steyerberg, Ewout W Wijnhoven, Bas PL van Lanschot, J Jan B |
| author_sort | Noordman, Bo Jan |
| collection | DOAJ |
| description | BackgroundResults from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49% of patients with a squamous cell carcinoma (SCC) and 23% of patients with an adenocarcinoma (AC) had a pathologically complete response in the resection specimen. These results provide a rationale to reconsider and study the timing and necessity of esophagectomy in (all) patients after application of the CROSS regimen.
ObjectiveWe propose a “surgery as needed” approach after completion of nCRT. In this approach, patients will undergo active surveillance after completion of nCRT. Surgical resection would be offered only to those patients in whom residual disease or a locoregional recurrence is highly suspected or proven. However, before a surgery as needed approach in oesophageal cancer patients (SANO) can be tested in a randomized controlled trial, we aim to determine the accuracy of detecting the presence or absence of residual disease after nCRT (preSANO trial).
MethodsThis study is set up as a prospective, single arm, multicenter, diagnostic trial. Operable patients with potentially curable SCC or AC of the esophagus or esophagogastric junction will be included. Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumor site and of any other suspected lesions in the esophagus and radial endo-ultrasonography (EUS) for measurement of tumor thickness and area. Patients in whom no locoregional or disseminated disease can be proven by cytohistology will be offered a postponed surgical resection 6-8 weeks after CRE-I (ie, approximately 12-14 weeks after completion of nCRT). In the week preceding the postponed surgical resection, a second clinical response evaluation (CRE-II) will be planned that will include a whole body PET-CT, followed again by endoscopy with (random) conventional mucosal biopsies of the primary tumor site and any other suspected lesions in the esophagus, radial EUS for measurement of tumor thickness and area, and linear EUS plus fine needle aspiration of PET-positive lesions and/or suspected lymph nodes. The main study parameter is the correlation between the clinical response assessment during CRE-I and CRE-II and the final pathological response in the resection specimen.
ResultsThe first patient was enrolled on July 23, 2013, and results are expected in January 2016.
ConclusionsIf this preSANO trial shows that the presence or absence of residual tumor can be predicted reliably 6 or 12 weeks after completion of nCRT, a randomized trial comparing nCRT plus standard surgery versus chemoradiotherapy plus “surgery as needed” will be conducted (SANO trial).
Trial RegistrationNetherlands Trial Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived by Webcite at http://www.webcitation.org/6Ze7mn67B). |
| first_indexed | 2024-12-23T22:59:14Z |
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| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-12-23T22:59:14Z |
| publishDate | 2015-06-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj.art-87f406bdb735427c9368740a2a4e747b2022-12-21T17:26:57ZengJMIR PublicationsJMIR Research Protocols1929-07482015-06-0142e7910.2196/resprot.4320Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and ProtocolNoordman, Bo JanShapiro, JoelSpaander, Manon CWKrishnadath, Kausilia Kvan Laarhoven, Hanneke WMvan Berge Henegouwen, Mark INieuwenhuijzen, Grard APvan Hillegersberg, RichardSosef, Meindert NSteyerberg, Ewout WWijnhoven, Bas PLvan Lanschot, J Jan BBackgroundResults from the recent CROSS trial showed that neoadjuvant chemoradiotherapy (nCRT) significantly increased survival as compared to surgery alone in patients with potentially curable esophageal cancer. Furthermore, in the nCRT arm 49% of patients with a squamous cell carcinoma (SCC) and 23% of patients with an adenocarcinoma (AC) had a pathologically complete response in the resection specimen. These results provide a rationale to reconsider and study the timing and necessity of esophagectomy in (all) patients after application of the CROSS regimen. ObjectiveWe propose a “surgery as needed” approach after completion of nCRT. In this approach, patients will undergo active surveillance after completion of nCRT. Surgical resection would be offered only to those patients in whom residual disease or a locoregional recurrence is highly suspected or proven. However, before a surgery as needed approach in oesophageal cancer patients (SANO) can be tested in a randomized controlled trial, we aim to determine the accuracy of detecting the presence or absence of residual disease after nCRT (preSANO trial). MethodsThis study is set up as a prospective, single arm, multicenter, diagnostic trial. Operable patients with potentially curable SCC or AC of the esophagus or esophagogastric junction will be included. Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumor site and of any other suspected lesions in the esophagus and radial endo-ultrasonography (EUS) for measurement of tumor thickness and area. Patients in whom no locoregional or disseminated disease can be proven by cytohistology will be offered a postponed surgical resection 6-8 weeks after CRE-I (ie, approximately 12-14 weeks after completion of nCRT). In the week preceding the postponed surgical resection, a second clinical response evaluation (CRE-II) will be planned that will include a whole body PET-CT, followed again by endoscopy with (random) conventional mucosal biopsies of the primary tumor site and any other suspected lesions in the esophagus, radial EUS for measurement of tumor thickness and area, and linear EUS plus fine needle aspiration of PET-positive lesions and/or suspected lymph nodes. The main study parameter is the correlation between the clinical response assessment during CRE-I and CRE-II and the final pathological response in the resection specimen. ResultsThe first patient was enrolled on July 23, 2013, and results are expected in January 2016. ConclusionsIf this preSANO trial shows that the presence or absence of residual tumor can be predicted reliably 6 or 12 weeks after completion of nCRT, a randomized trial comparing nCRT plus standard surgery versus chemoradiotherapy plus “surgery as needed” will be conducted (SANO trial). Trial RegistrationNetherlands Trial Register: NTR4834; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4834 (archived by Webcite at http://www.webcitation.org/6Ze7mn67B).http://www.researchprotocols.org/2015/2/e79/ |
| spellingShingle | Noordman, Bo Jan Shapiro, Joel Spaander, Manon CW Krishnadath, Kausilia K van Laarhoven, Hanneke WM van Berge Henegouwen, Mark I Nieuwenhuijzen, Grard AP van Hillegersberg, Richard Sosef, Meindert N Steyerberg, Ewout W Wijnhoven, Bas PL van Lanschot, J Jan B Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol JMIR Research Protocols |
| title | Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol |
| title_full | Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol |
| title_fullStr | Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol |
| title_full_unstemmed | Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol |
| title_short | Accuracy of Detecting Residual Disease After Cross Neoadjuvant Chemoradiotherapy for Esophageal Cancer (preSANO Trial): Rationale and Protocol |
| title_sort | accuracy of detecting residual disease after cross neoadjuvant chemoradiotherapy for esophageal cancer presano trial rationale and protocol |
| url | http://www.researchprotocols.org/2015/2/e79/ |
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