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Organ Motion and Early Tumor Response Measurement

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ClinicalTrials.gov Identifier: NCT02139488
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment
Esophageal Cancer Chemoradiation 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 Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer
Actual Study Start Date : April 18, 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139488


Locations
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Netherlands
The Netherlands cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Francine Voncken, MD NKI-AvL
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02139488    
Other Study ID Numbers: N13OME
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data of two clinic trials will be joined for MRI scans
Keywords provided by The Netherlands Cancer Institute:
Esophageal cancer
Chemoradiation
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases