About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Pre-Surgery If Needed for Oesophageal Cancer

Clinicaltrials.gov identifier NCT03937362

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted August 12, 2019

Study Description

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:Esophageal Cancer
  • Intervention/Treatment: Diagnostic Test: First clinical response evaluation (CRE-1)
    Diagnostic Test: Second clinical response evaluation (CRE-2)
  • Phase: N/A
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).

Study Design
  • 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 2019
  • Estimated Primary Completion Date: August 2022
  • Estimated Study Completion Date: August 2022
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • 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+).
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts

Contact: Xiaobin Zhang, MD 18516302162 ext 18960619260 zxb5212@163.com

Contact: Zhiang Li 18960619260 ext 18960619260 dr_lizhigang@163.com

Locations

China
Shanghai Chest Hospital
Shanghai

China
Tianjin Medical University Cancer Institute and Hospital
Tianjin

Hong Kong
Queen Mary Hospital
Hong Kong

Taiwan
Chang Gung Memorial Hospital
Linkou

Sponsors and Collaborators

Shanghai Chest Hospital

Tianjin Medical University Cancer Institute and Hospital

Chang Gung Memorial Hospital

Queen Mary Hospital, Hong Kong

Investigators

Principal Investigator: Zhigang Li, MD, PhD Shanghai Chest Hospital

More Information
  • Responsible Party: Shanghai Chest Hospital
  • ClinicalTrials.gov Identifier: NCT03937362 History of Changes
  • 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
  • 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.: Yes
  • Keywords provided by Shanghai Chest Hospital: Active surveillance
    Esophagectomy
    Neoadjuvant chemoradiotherapy
    Esophageal cancer
    Esophageal squamous cell carcinoma
  • Additional relevant MeSH terms: Esophageal Neoplasms Esophageal Squamous Cell Carcinoma