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Organ motion and early tumor response measurement during chemoradiotherapy for esophageal cancer.

Organ motion and early tumor response measurement during chemoradiotherapy for esophageal cancer. - Organ motion and early tumor response measurement

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44849
Enrollment
50
Registered
2013-12-03
Start date
2014-04-18
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

esophageal cancer

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus • Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy • T3N0M0 or T1-4N1-3M0. Patients with M1 disease solely on the basis of supraclavicular metastasis and not a junction tumor as primary are eligible. (AJCC 7th edition) • WHO performance status = 18 years • Written informed consent before endoscopy or EUS

Exclusion criteria

Exclusion criteria: • Prior treatment with thoracic surgery or thoracic radiotherapy • Pregnancy • Severe cardiopulmonary restriction

Design outcomes

Primary

MeasureTime frame
Primary endpoint of this study is to quantify motion of the esophageal tumor over the course of chemoradiation. Fiducial markers placed in the esophageal wall will be taken as surrogate position of the tumor. By matching the markers on the reference scan the motion variables can be obtained. These different variables are necessary to calculate the corresponding PTV margin. These motion variables are; • Bony anatomy setup error, this is defined as the discordance between the patient*s position from baseline treatment planning position by external fiducial markers and the bony setup correction deriving from the CBCT • Peak-to-peak amplitude of the GTV/CTV by breathing motion • Baseline shifts (inter and intra fraction) • Inter-fraction motion; defined as the motion in between 2 radiation fractions • Intra-fraction motion; defined as the motion occurring within the time period of a single daily fraction

Secondary

MeasureTime frame
• Peak to peak amplitudes of mid-thoracic versus distal/ GE-junctional tumors • Correlation of tumor response on FDG-PET scan (SUV decline) and DCE-MRI (change in Ktrans) with pathological response for trimodality patients • Correlation of combined PET and DCE-MRI results with pathological response for trimodality patients • SUVmax of the primary tumor on 3D versus 4D PET • DCE*MRI of the esophagus for treatment planning and response monitoring •* Ease of insertion, migration and visibility of different fiducial markers

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)