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Table 1 Study process

From: Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study

Parameter

Baseline

nCRT

CRE-1

CRE-2

Surgery

Follow-up

History, physical examination

Yes

Yes

Yes

Yes

Yes

Yes

ECOG Performance Status

Yes

Yes

    

Hematologya

Yes

Yes

    

Biochemistryb

Yes

Yes

    

Toxicity (CTCAE v5)

 

Yesc

    

ECG

Yes

   

Ind.

 

Pulmonary function test

Yes

   

Ind.

 

Bronchoscopy

Ind.d

   

Ind.d

 

High resolution CT

Yes

 

Ind.e

   

External ultrasound of the neck

Yes

     

Written informed consent

Yes

     

EGD with ≥4 bite-on-bite biopsiesf

Yesf

 

Yes

Yes

  

EUS with FNAg

Ind.

  

Yes

  

PET-CT

Yes

 

Ind.e

Yes

 

Yesh

QoL questionnairesi

Yes

  

Yes

 

Yesi

  1. nCRT neoadjuvant chemoradiotherapy, CRE-1 first clinical response evaluation, four to six weeks after completion of nCRT, CRE-2 second clinical response evaluation, 10–12 weeks after completion of nCRT, Yes test will be performed, Ind test will be performed only on indication, ECOG Eastern Cooperative Oncology Group, CTCAE v5 Common Terminology Criteria for Adverse Events version 5, ECG Electrocardiography, CT computed tomography, EGD esophagogastroduodenoscopy, EUS endoscopic ultrasonography, FNA fine-needle aspiration, PET-CT positron emission tomography with computed tomography, QoL quality of life
  2. a Hematology: complete blood count and differential blood count;
  3. b Biochemistry: serum protein, albumin, sodium, potassium, chloride magnesium, serum creatinine, eGFR, bilirubin, alkaline phosphatase, AST, and pregnancy test if indicated;
  4. c Toxicity according to the CTCAE v5 will be assessed after each cycle of chemotherapy;
  5. d Bronchoscopy: in case of suspected tracheobronchial invasion based on other diagnostics;
  6. e In case of histological evidence of locoregional residual disease at CRE, a whole body PET-CT scan or CT scan will be made to exclude distant metastases;
  7. f Only during EGD at baseline it suffices if regular biopsies are taken instead of bite-on-bite biopsies;
  8. g FNA will be performed of all suspected lymph nodes based on prior PET-CT and based on assessment during EUS;
  9. h Follow-up PET-CT scans will be made at 16 and 30 months after completion of nCRT in patients who show a clinically complete response after CRE-2 to allow for comparison of distant dissemination rate in the future SINO trial;
  10. i QoL questionnaires EQ-5D, QLQ-C30, QLC-OG25 and Cancer Worry Scale will be taken at baseline, between CRE-2 and surgery. In patients who show a clinically complete response after CRE-2 and undergo immediate surgery questionnaires will also be taken at 6, 9, 12, 16, 20 and 24 months after completion of nCRT to allow for comparison in the future SINO trial
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BMC Cancer

ISSN: 1471-2407

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