esophageal cancer response
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Histologically proven esophageal cancer (SCC and AC). 2. Age 18 years or older. 3. Able to give written informed consent before registration. 4. T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer. 5. Potentially curatively (R0) resectable tumor. 6. Tumor should have sufficient FDG-baseline uptake (in case routine baseline FDG-PET/CT shows insufficient uptake no additional MRI will be made). 7. Able to tolerate PET-CT and DWI-MRI as required by protocol. 8. Patients eligible for neo-adjuvant chemoradiotherapy (CRT), including a Karnofsky Performance Score (KPS) >= 70% / WHO>2, adequate renal, hepatic, hematological function. 9. No prior chemotherapy or mediastinal radiotherapy allowed. 10. Written informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Non-resectable tumours 2. Proven distant metastases 3. Prior malignancy except in-situ cervical lesions and/or non-melanoma skin cancer in the past 5 years. 4. Poorly controlled diabetes 5. Medical comorbidity preventing from surgery/preop CRT 6. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Tumor response (complete or partial) during and after neo-adjuvant CRT. Clinical response will be assessed by PET/CT (SUVmax) and by DWI-MRI (ADC; the stronger the diffusion, the greater the diffusion coefficient) either alone or in a combined approach (PET/MRI) when available. The assessed clinical response (cR) will be correlated to the pathologic response (pR) on the resected specimen according to a standard protocol. The value of both imaging methods will be determined alone and combined to assess both early (around 2 weeks) and late responses (>= 2 weeks after the end of CRT) . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Determining disease free survival (DFS) after different response type (clinical complete response =cCR or pathologic complete response = pCR) at T1 (early volumetric and functional response) and at T2 (post CRT=histological response /volumetric and functional) comparing pathologic status with blinded reading of PET/CT and DWI-MRI from two independent radiologists/nuclear medicine physicians. Assessment of no response or progression at T1 for a better selection of patients to early definitive surgery. Moreover, at T1 cCR will be assessed and at T2 cCR and pCR will be determined. Determining the changes in radiotherapy target volume delineation by the additional use of MRI. | — |
Countries
Netherlands
Outcome results
None listed