- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839109
PET-CT vs DWI-MRI in Response Evaluation in Esophageal Cancer (PET/MRI-EC)
PET-CT and DWI-MRI in Evaluating and Predicting Response to Neo-adjuvant Chemoradiotherapy in Esophageal Cancer Patients
In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) has shown potential benefits, which might be enhanced by combining both methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions and seem to assess post-treatment changes, especially regarding nodal staging. Both techniques claim an important role in selection of patients with clinical complete response (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact role and complementary effects of both techniques is still unknown.
For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery, approximately 6-10 weeks after nCRT and compared with the situation at primary staging. Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0) after nCRT may refrain from surgical resection and related morbidity and mortality. However, patients without early (2wk after commencement) response during nCRT course may not benefit from nCRT.
DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Histologically proven esophageal cancer (SCC and AC).
- Age of 18 years or older.
- Able to give written informed consent before registration.
- T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer.
- Potentially curatively (R0) resectable tumor.
- Tumor have sufficient FDG-baseline uptake.
- Able to tolerate PET-CT and DWI-MRI as required by protocol.
- Eligible for neo-adjuvant chemoradiotherapy (nCRT), including KPScore ≥ 70% / WHO>2; adequate renal, hepatic, hematological function.
- No prior chemotherapy or mediastinal radiotherapy allowed.
Exclusion Criteria:
- Non-resectable tumors: clinical or pathologic (T4b/R1-2 resections).
- Proven distant metastases.
- Prior malignancy except in-situ cervical lesions or non-melanoma skin cancer in the past 5 years.
- Poorly controlled diabetes
- Medical comorbidity preventing from surgery/preop CRT
General contraindications to MRI:
- implanted pacemaker/serious claustrophobia
- aneurysmal clips/metal implants in field of view
6. Major obesity (BMI > 40). 7. Active esophagitis. 8. Breast feeding/Pregnancy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Tumor response
Time Frame: Assessing clinical and pathologic response
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Within 2 weeks (early response) and at 6-10 weeks (late response)
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Assessing clinical and pathologic response
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Disease free survival (DFS)
Time Frame: at 6 months, 1 year and 2 years
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at 6 months, 1 year and 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: John Plukker, MD, PhD, Department of Surgical Oncology, University Medical Center Groningen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL49621.042.14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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