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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

Tracking Information
First Submitted Date March 31, 2014
First Posted Date May 15, 2014
Last Update Posted Date June 27, 2019
Actual Study Start Date April 18, 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Organ Motion and Early Tumor Response Measurement
Official Title Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer
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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Esophageal Cancer
  • Chemoradiation
Intervention
  • Other: Fiducial markers
  • Other: Fiducial markers, Pet and MRI
    Insertion of Fiducial markers in esophageal wall.
Study Groups/Cohorts neoadjuvant or definitive chemoradiation
Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation.
Interventions:
  • Other: Fiducial markers
  • Other: Fiducial markers, Pet and MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2019)
80
Original Estimated Enrollment
 (submitted: May 12, 2014)
54
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02139488
Other Study ID Numbers N13OME
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: data of two clinic trials will be joined for MRI scans
Responsible Party The Netherlands Cancer Institute
Study Sponsor The Netherlands Cancer Institute
Collaborators Not Provided
Investigators
Principal Investigator: Francine Voncken, MD NKI-AvL
PRS Account The Netherlands Cancer Institute
Verification Date June 2019