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Pre-Surgery If Needed for Oesophageal Cancer (preSINO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Tianjin Medical University Cancer Institute and Hospital
Chang Gung Memorial Hospital
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
Zhiang Li, Shanghai Chest Hospital

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).

Condition or disease Intervention/treatment
Esophageal Cancer Diagnostic Test: First clinical response evaluation (CRE-1) Diagnostic Test: Second clinical response evaluation (CRE-2)

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
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria are:

  1. Histologically confirmed esophageal squamous cell carcinoma;
  2. Tumor located in the chest;
  3. Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer;
  4. Age > 20 at the date of informed consent;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less;
  6. Considered fit to undergo nCRT followed by surgical resection;
  7. Expected survival time more than three months;
  8. Written informed consent by the patient.

Exclusion criteria are:

  1. Patient with a second primary tumor;
  2. Previous major surgery in the chest or upper abdomen;
  3. Tumor not 18F-FDG-avid at baseline PET-CT;
  4. Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area;
  5. Primary (early) lesion already removed by EMR/ESD;
  6. Previous history of chemotherapy and/or radiation therapy;
  7. Cervical esophageal cancer.

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaobin Zhang, MD 18516302162 ext 18960619260 zxb5212@163.com
Contact: Zhiang Li 18960619260 ext 18960619260 dr_lizhigang@163.com

Locations
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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         
Sponsors and Collaborators
Shanghai Chest Hospital
Tianjin Medical University Cancer Institute and Hospital
Chang Gung Memorial Hospital
Queen Mary Hospital, Hong Kong
Investigators
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Principal Investigator: Zhigang Li, MD, PhD Shanghai Chest Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhiang Li, Chief, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03937362    
Other Study ID Numbers: Chest201902
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zhiang Li, Shanghai Chest Hospital:
Esophagectomy
Neoadjuvant chemoradiotherapy
Esophageal cancer
Esophageal squamous cell carcinoma
Active surveillance
Additional relevant MeSH terms:
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Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell