An observational study in Esophageal Cancer, Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, sponsored by UMC Utrecht. Status unknown at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by UMC Utrecht · Observational
Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of the response to nCRT and is associated with substantial morbidity. Prior knowledge of the eventual response to nCRT would greatly impact on the optimal care for many esophageal cancer patients for two imperative reasons:
Firstly, it is argued that patients who achieved a pathologic complete response (pCR, 29%) may not have benefitted from surgery. Consequently, proper identification of pathological complete responders prior to surgery could yield an organ-preserving regimen avoiding unnecessary toxicity.
Secondly, non-responders are exposed to the side effects of nCRT without showing any tumor regression. Early identification of the non-responders during nCRT would be beneficial for this group as ineffective therapy could be stopped, and for who altered treatment strategies could be explored.
Objective: To develop a multimodal model that predicts the probability of pathologic complete response to nCRT in esophageal cancer, by integrating diffusion weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in conjunction with combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (18F-FDG PET-CT) scans acquired prior to, during and after administration of nCRT.
Study design: Multi-center observational study
Study population: Patients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT prior to surgery.
Intervention: In addition to the standard diagnostic work-up for esophageal cancer that includes a 18F-FDG PET-CT scan at diagnosis and after nCRT, one 18F-FDG PET-CT scans will be performed during nCRT, as well as three MRI scans (before, during and after nCRT) within fixed time intervals. Furthermore, after response imaging after nCRT has been performed, but prior to surgery, patients will undergo (on an opt-out basis) an endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site, other suspected lesions and suspected lymph nodes. Furthermore, blood samples will be collected at three time points.
Main study parameters/endpoints: An accurate multimodal prediction model for the patients' individual probability of pathologic complete response after nCRT, based on the quantitative parameters derived from a longitudinal series of DW-MRI, DCE-MRI and 18F-FDG PET-CT datasets.
675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
This study's planned enrollment of 200 is below the median of 247 across 86 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
Compared within Esophageal Squamous Cell Carcinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Esophageal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with resectable esophageal or gastroesophageal junction adeno- or squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy according to the CROSS-regimen
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who meet exclusion criteria for intravenous gadolinium-based contrast:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients (\>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT according to the CROSS regimen prior to surgery. CROSS regimen: weekly carboplatin (doses titrated to achieve an area under the curve of 2 mg per milliliter per minute) and paclitaxel (50 mg per square meter of body-surface area) for 5 weeks and concurrent radiotherapy (41.4 Gy in 23 fractions, delivered 5 days per week on workdays with intensity modulated radiotherapy, including photon and proton therapy)
Diagnostic Test: MRI · Diagnostic Test: PET-CT · Diagnostic Test: Endoscopy · Diagnostic Test: Blood samples
* Anatomical (T2W) and functional MRI (DWI and DCE) at a 1.5T Siemens or Philips scanner * DWI series: sagittal (sIVIM) and high-resolution transversal (HR tDWI) * DCE serie: dynamic20 * In total, three MRI scan series (before, during, after nCRT) * Measurements: i.a. change in apparent diffusion coefficient (ADC) or area-under-the-gadolinium-concentration time curve (AUC) within tumor delineation over time, radiological (qualitative) assessment of residual disease
Also known as: Magnetic Resonance Imaging, DW-MRI, DCE-MRI, T2W
* According to European Association of Nuclear Medicine (EANM) Research Ltd guidelines (EARL) * In total one additional PET-CT (during nCRT) for study purposes. A PET-CT scan at diagnosis and after nCRT are included in the standard diagnostic work-up for esophageal cancer. * Measurements: i.a. change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value) or Ktrans within tumor delineation over time
Also known as: 18-F FDG PET-CT, PET
Additional endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site and other suspected lesions in the esophagus after completion of nCRT and prior to surgery
Also known as: Endoscopic assessment, EUS
* Blood samples at three different time points (before, during and after nCRT) will be collected * Blood will be collected in cell-free DNA collection tubes * Purpose: isolation of ctDNA and subsequent mutation analysis by means of Next Generation Sequencing * Measurements: the presence of, and changes in, ctDNA during nCRT
Also known as: ctDNA
Histopathologic response
Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist. TRG 1: no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change
Time frame: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Pathological T- and N-stage
Pathological T- and N-stage as determined by expert pathologist (based on the American Joint Committee on Cancer \[AJCC\] Tumor Node Metastasis \[TNM\] staging system)
Time frame: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Disease-free survival.
Disease-free survival based on local follow-up policies (time to locoregional or distal recurrence of esophageal cancer).
Time frame: Up to 5-year follow-up
Overall survival.
Overall survival based on local follow-up policies.
Time frame: Up to 5-year follow-up
Plan to share: Undecided
Started Apr 2018 (actual). Primary completion is estimated for Sep 2021, 41 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Esophageal Squamous Cell Carcinoma →