Organ Motion and Early Tumor Response Measurement

• ClinicalTrials.gov Identifier: NCT02139488
• Recruitment Status: Completed
• First Posted: May 15, 2014
• Last Update Posted: June 27, 2019
• Sponsor: The Netherlands Cancer Institute
• 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
• 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

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

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