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Pre-Surgery If Needed for Oesophageal Cancer (preSINO)
| 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 |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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+).
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion criteria are:
- Histologically confirmed esophageal squamous cell carcinoma;
- Tumor located in the chest;
- Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer;
- Age > 20 at the date of informed consent;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less;
- Considered fit to undergo nCRT followed by surgical resection;
- Expected survival time more than three months;
- Written informed consent by the patient.
Exclusion criteria are:
- Patient with a second primary tumor;
- Previous major surgery in the chest or upper abdomen;
- Tumor not 18F-FDG-avid at baseline PET-CT;
- Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area;
- Primary (early) lesion already removed by EMR/ESD;
- Previous history of chemotherapy and/or radiation therapy;
- Cervical esophageal cancer.
| Contact: Xiaobin Zhang, MD | 18516302162 ext 18960619260 | zxb5212@163.com | |
| Contact: Zhiang Li | 18960619260 ext 18960619260 | dr_lizhigang@163.com |
| China | |
| Shanghai Chest Hospital | Recruiting |
| Shanghai, China | |
| Contact: Zhigang Li, MD, PhD | |
| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting |
| Tianjin, China | |
| Contact: Zhen-Tao Yu, MD, PhD | |
| Hong Kong | |
| Queen Mary Hospital | Not yet recruiting |
| Hong Kong, Hong Kong | |
| Contact: Simon Law, MD, PhD | |
| Taiwan | |
| Chang Gung Memorial Hospital | Not yet recruiting |
| Linkou, Taiwan | |
| Contact: Yin-Kai Chao, MD, PhD | |
| Principal Investigator: | Zhigang Li, MD, PhD | Shanghai Chest Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 1, 2019 | ||||||||
| First Posted Date | May 3, 2019 | ||||||||
| Last Update Posted Date | August 12, 2019 | ||||||||
| Actual Study Start Date | August 8, 2019 | ||||||||
| Estimated Primary Completion Date | August 8, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures |
Accuracy of clinical response evaluations for detecting substantial residual tumor [ 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) in the surgical resection specimen.
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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+).
|
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| Original Secondary Outcome Measures |
Accuracy of clinical response evaluations for detecting any residual tumor [ 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+).
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Pre-Surgery If Needed for Oesophageal Cancer | ||||||||
| 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) | ||||||||
| Brief Summary | Prospective, multi-centre, diagnostic cohort study investigating the accuracy of positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) for detecting residual disease after neoadjuvant chemoradiotherapy in patients with potentially curable esophageal squamous cell carcinoma (SCC). | ||||||||
| Detailed Description |
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). |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Esophageal cancer patients who are planned to undergo nCRT according to the CROSS regimen and who will undergo surgical resection will be recruited from four Asian centres. | ||||||||
| Condition | Esophageal Cancer | ||||||||
| Intervention |
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| Study Groups/Cohorts | 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. Interventions:
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| Publications * | Zhang X, Eyck BM, Yang Y, Liu J, Chao YK, Hou MM, Hung TM, Pang Q, Yu ZT, Jiang H, Law S, Wong I, Lam KO, van der Wilk BJ, van der Gaast A, Spaander MCW, Valkema R, Lagarde SM, Wijnhoven BPL, van Lanschot JJB, Li Z. Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study. BMC Cancer. 2020 Mar 6;20(1):194. doi: 10.1186/s12885-020-6669-y. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 8, 2022 | ||||||||
| Estimated Primary Completion Date | August 8, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion criteria are:
Exclusion criteria are:
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China, Hong Kong, Taiwan | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03937362 | ||||||||
| Other Study ID Numbers | Chest201902 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Zhiang Li, Shanghai Chest Hospital | ||||||||
| Study Sponsor | Shanghai Chest Hospital | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Shanghai Chest Hospital | ||||||||
| Verification Date | August 2019 | ||||||||
