Preoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24280

Enrollment

Registered

2013-05-02

Start date

2013-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer. MRI. PET-CT. Oesofaguscarcinoom. Slokdarmkanker.

Interventions

1. Three MRI scans: Pre-, per- and post-chemoradiation therapy

2. Three PET-CT scans: Pre-, per- and post-chemoradiation therapy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy); 2. Potentially resectable tumor (cT1b-4a N0-3 M0); 3. Undergoing neoadjuvant chemoradiation according to CROSS-regimen; 4. Age >18 years; 5. No history of other cancer or previous radiotherapy or chemotherapy; 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the Radiology department of the UMC Utrecht; 2. Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMC Utrecht protocol ‘Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012’. In patients with risk factors a minimum GFR of 60 mL/min/1.73m2 will be required; 3. Patients with insulin dependent diabetes mellitus or a blood plasma glucose concentration higher than 10 mmol/L; 4. Patients with a known Gadovist allergy; 5. Patients with a known CT-contrast allergy; 6. Patients having difficulty understanding Dutch; 7. Pregnant or breast-feeding patients.

Design outcomes

Primary

Measure	Time frame
The additional diagnostic value -in terms of accuracy, sensitivity, specificity and predicitve values- of anatomical and functional MRI to PET-CT in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer, as compared to the pathological specimen as gold standard.	—

Secondary

Measure	Time frame
1. Assessment of the optimal (MRI and PET-CT) imaging parameters that correlate best with pathological response; 2. Assessment of the optimal timing for the imaging series; 3. Assessment of the diagnostic value of MRI for post-nCRT restaging of T- and N-stage as compared to histopathology; 4. Assessment of the experienced burden for the patient associated with extra MRI and PET-CT scanning in the clinical work-up for esophageal cancer, as determined by a self-administered questionnaire.	—

Measure

Time frame

1. Assessment of the optimal (MRI and PET-CT) imaging parameters that correlate best with pathological response; 2. Assessment of the optimal timing for the imaging series; 3. Assessment of the diagnostic value of MRI for post-nCRT restaging of T- and N-stage as compared to histopathology; 4. Assessment of the experienced burden for the patient associated with extra MRI and PET-CT scanning in the clinical work-up for esophageal cancer, as determined by a self-administered questionnaire.

—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)