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OpenTrials
Completed

NCT Number: NCT02139488

Organ Motion and Early Tumor Response Measurement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Netherlands cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≤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

Exclusion criteria

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

Treatment and study plan

Fiducial markers

Other

Fiducial markers, Pet and MRI

Other

Insertion of Fiducial markers in esophageal wall.

Primary outcomes

  1. To quantify motion of the esophageal tumor over the course of chemoradiation

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 15, 2014
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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