Pre-Surgery If Needed for Oesophageal Cancer (preSINO)
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|ClinicalTrials.gov Identifier: NCT03937362|
Recruitment Status : Unknown
Verified August 2019 by Zhiang Li, Shanghai Chest Hospital.
Recruitment status was: Recruiting
First Posted : May 3, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Diagnostic Test: First clinical response evaluation (CRE-1) Diagnostic Test: Second clinical response evaluation (CRE-2)|
After neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically complete response (pCR) rates are being achieved in patients with squamous cell carcinoma (SCC). An active surveillance strategy has been proposed for SCC patients with clinically complete response (cCR) after nCRT. To justify omitting surgical resection, patients with residual disease should be accurately identified.
The objective of this study is to assess the accuracy of response evaluations after nCRT based on the preSANO trial, including positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC.
Operable esophageal SCC patients who are planned to undergo nCRT according to the CROSS regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to six weeks after completion of nCRT, patients will undergo a first clinical response evaluation (CRE-1) consisting of endoscopic bite-on-bite biopsies. In patients without histological evidence of residual tumor (i.e. without positive biopsies), surgery will be postponed another six weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopic bite-on-bite biopsies and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of single diagnostic modalities will be correlated to pathological response in the resection specimen for calculation of sensitivity, specificity, negative predictive value and positive predictive value.
If the current study shows that major residual disease (>10% residual carcinoma at the primary tumor site and any residual nodal disease) can be accurately (i.e. with sensitivity of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted comparing active surveillance with standard esophagectomy in patients with a clinically complete response after nCRT (SINO trial).
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Accuracy of Detecting Residual Disease After Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: the preSINO Trial (Pre-Surgery If Needed for Oesophageal Cancer)|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||August 8, 2022|
|Estimated Study Completion Date :||August 8, 2022|
Clinical Response Evaluation
Patients with operable esophageal squamous cell carcinoma who are planned to undergo neoadjuvant chemoradiotherapy according to the CROSS regimen (intravenous carboplatin AUC 2 mg/mL/min and intravenous paclitaxel 50 mg/m2 on days 1, 8, 15, 22 and 29 with concurrent 41.4 Gy radiotherapy given in 23 fractions of 1.8 Gy on 5 days per week) followed by surgery.
Patients will undergo a first clinical response evaluation (CRE-1) 4-6 week after completion of nCRT. In patients without histological evidence of residual tumor surgery will be postponed another 6 weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy.
Diagnostic Test: First clinical response evaluation (CRE-1)
Consisting of: endoscopy with bite-on-bite biopsies
Diagnostic Test: Second clinical response evaluation (CRE-2)
Consisting of: PET-CT, endoscopic bite-on-bite biopsies,EUS with FNA
- Accuracy of clinical response evaluations for detecting substantial residual locoregional disease [ Time Frame: 10-12 weeks after completion of neoadjuvant chemoradiotherapy ]The diagnostic performance in terms of sensitivity and specificity of both CRE-1 and CRE-2 for detecting TRG 3-4 residual tumor (more than 10% residual carcinoma) or TRG 1-2 residual tumor (less than 10% residual carcinoma) with residual nodal disease (ypN+) in the surgical resection specimen.
- Accuracy of clinical response evaluations for detecting any residual locoregional disease [ Time Frame: 10-12 weeks after completion of neoadjuvant chemoradiotherapy ]The diagnostic performance in terms of sensitivity and specificity of both CRE-1 and CRE-2 for detecting pathologically non-complete response in both the primary tumor and the regional lymph nodes (TRG2-4 or ypN+).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937362
|Contact: Xiaobin Zhang, MD||18516302162 ext firstname.lastname@example.org|
|Contact: Zhiang Li||18960619260 ext email@example.com|
|Shanghai Chest Hospital||Recruiting|
|Contact: Zhigang Li, MD, PhD|
|Tianjin Medical University Cancer Institute and Hospital||Not yet recruiting|
|Contact: Zhen-Tao Yu, MD, PhD|
|Queen Mary Hospital||Not yet recruiting|
|Hong Kong, Hong Kong|
|Contact: Simon Law, MD, PhD|
|Chang Gung Memorial Hospital||Not yet recruiting|
|Contact: Yin-Kai Chao, MD, PhD|
|Principal Investigator:||Zhigang Li, MD, PhD||Shanghai Chest Hospital|