Organ Motion and Early Tumor Response Measurement

NCT02139488 | Completed

• 1 other identifier: N13OME
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.

Conditions

Esophageal Cancer; Chemoradiation

Keywords

Esophageal cancer; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• To quantify motion of the esophageal tumor over the course of chemoradiation

  The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome) By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed.

  6 weeks

Study Arms (1)

neoadjuvant or definitive chemoradiation

Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation.

Other: Fiducial markers; Other: Fiducial markers, Pet and MRI

Interventions

Fiducial markers OTHER

neoadjuvant or definitive chemoradiation

Fiducial markers, Pet and MRI OTHER

Insertion of Fiducial markers in esophageal wall.

neoadjuvant or definitive chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus * Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy

You may qualify if:

• 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 ≤2 (WHO scale)
• Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality
• Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia
• Age ≥ 18 years
• Written informed consent before endoscopy or EUS

You may not qualify if:

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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

The Netherlands cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

Related Publications (1)

• Vollenbrock SE, Voncken FEM, Lambregts DMJ, Maas M, Donswijk ML, Vegt E, Ter Beek LC, van Dieren JM, van Sandick JW, Aleman BMP, Beets-Tan RGH, Bartels-Rutten A. Clinical response assessment on DW-MRI compared with FDG-PET/CT after neoadjuvant chemoradiotherapy in patients with oesophageal cancer. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):176-185. doi: 10.1007/s00259-020-04917-5. Epub 2020 Jun 22.

  PMID: 32572560 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Fiducial Markers; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Reference Standards; Weights and Measures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies; Radiation Equipment and Supplies; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Francine Voncken, MD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: May 15, 2014
• Study Start: April 18, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)