Organ Motion and Early Tumor Response Measurement

Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer; Chemoradiation
• Intervention / Treatment: Other: Fiducial markers; Other: Fiducial markers, Pet and MRI

Detailed Description

A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.

Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.

Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1066CX
      • The Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus
2. Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy
3. 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,).
4. WHO performance status ≤2 (WHO scale)
5. Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality
6. Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia
7. Age ≥ 18 years
8. Written informed consent before endoscopy or EUS

Exclusion criteria:

1. Prior treatment with thoracic surgery or thoracic radiotherapy
2. Pregnancy
3. Severe cardiopulmonary restriction

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
neoadjuvant or definitive chemoradiation; Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation.	Other: Fiducial markers; Other: Fiducial markers, Pet and MRI; Insertion of Fiducial markers in esophageal wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2014
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (ESTIMATE): May 15, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Chemoradiation; Esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: N13OME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data of two clinic trials will be joined for MRI scans