PReoperative Identification Of Response to Neoadjuvant Chemoradiotherapy for Esophageal Cancer

Completed

Conditions studied: Esophageal Cancer

In brief

Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed independent of the response to nCRT and is associated with substantial morbidity. A pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity and delay from surgical therapy inevitably occurs in this group. Early identification of non-responders during nCRT would allow individualized decision making in continuation or discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment response after nCRT to identify patients with a complete response. Studies in rectal cancer reported that tumor resection could be omitted in patients with persisting clinical complete response after 12 months. Also, in some esophageal cancer studies, complete responders in surgical and non-surgical treatment groups had comparable overall survival. These findings indicate the possibility to perform nCRT as sole treatment in patients with a complete response. Conversely, if residual tumor is demonstrated, this will support the decision to move to surgery. Objective: Diagnostic study to assess the distinct and combined value of anatomical and functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to nCRT for patients with esophageal cancer. Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the imaging before, during and after nCRT for assessment of response to nCRT for resectable esophageal cancer. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard. Study population: 50 patients (\>18 years) presenting at the UMC Utrecht or M.D. Anderson Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy, computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to surgery. Procedure: In addition to the conventional diagnostic work-up for esophageal cancer including a standard PET-CT before nCRT, two PET-CT scans will be performed during and after nCRT as well as three MRI scans before, during and after nCRT at the same time points. The first MRI (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the start of nCRT. The second scan session will take place after 10-14 days after the start of nCRT. The third and final scan session will be planned 1-2 weeks before surgery. Main study parameters/endpoints: Determination of the distinct and combined diagnostic value of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT for patients with esophageal cancer. Important imaging parameters include apparent diffusion coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the different time points. The differences of these values between time points are of particular interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%), negative predictive value (%), positive predictive value (%), and accuracy (%) of the different imaging parameters for correctly identifying histopathological complete response will be calculated.

Key facts

Study ID: NCT02125448
Run by: Gert Meijer
People needed: 30
Starts: 2013-10-01
Expected to finish: 2016-11-01
Last updated by the study team: 2020-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed squamous-cell carcinoma, adenocarcinoma or large-cell undifferentiated carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy)
Potentially resectable tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and CT
Undergoing preoperative chemoradiation according to CROSS-regimen
Age>18 years
No history of other cancer or previous radiotherapy or chemotherapy
Signed informed consent

You may not qualify if…

Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the department of Radiology of the UMC Utrecht
Patients who meet exclusion criteria for intravenous contrast (Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nephropathy according to the UMC Utrecht protocol 'Prevention contrast reaction and contrast nephropathy, Version 2 February 2012'). In patients with risk factors (2 or more of the following: 'peripheral vascular disease, heart failure, age >75 years, anemia, symptomatic hypotension, dehydration, use of diuretics or non-steroidal anti-inflammatory drugs)', a minimum GFR of 60 mL/min/1.73m2 will be required
Patients with insulin dependent diabetes mellitus or blood plasma glucose concentration higher than 10 mmol/L
Patients with a known Gadovist allergy
Patients with a known CT-contrast allergy
Patients having difficulty understanding Dutch
Pregnant or breast-feeding patients

Where it is running

M.D. Anderson Cancer Center — Houston, Texas, United States
University Medical Center Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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