Esophageal CancerNCT02139488
Organ Motion and Early Tumor Response Measurement
An observational study of Esophageal Cancer and Chemoradiation, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Chemoradiation
- What is being tested?
- Fiducial markers and Fiducial markers, Pet and MRI
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Apr 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Prior treatment with thoracic surgery or thoracic radiotherapy
- Pregnancy
- Severe cardiopulmonary restriction
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands cancer Institute
Amsterdam, North Holland, 1066CX
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer, Chemoradiation
- Being tested
- Fiducial markers, Fiducial markers, Pet and MRI
- Keywords
- Esophageal cancer, Chemoradiation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiducial markersOther
Fiducial markers, Pet and MRIOther
Insertion of Fiducial markers in esophageal wall.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant or definitive chemoradiation | Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation. Receives: Other: Fiducial markers; Other: Fiducial markers, Pet and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start18 Apr 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francine Voncken, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139488
- Sponsor's protocol ID
- N13OME
- Status last verified
- Jun 2019
- First submitted
- 31 Mar 2014
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: data of two clinic trials will be joined for MRI scans
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.
PubMed 32572560
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02139488
- Acronym / sponsor ID
- N13OME
- Conditions
- Esophageal Cancer, Chemoradiation
- Keywords
- Esophageal cancer, Chemoradiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 18 Apr 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant or definitive chemoradiation | – | Other: Fiducial markers, Other: Fiducial markers, Pet and MRIEsophageal cancer patients planned for neoadjuvant or definitive chemoradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Prior treatment with thoracic surgery or thoracic radiotherapy
- Pregnancy
- Severe cardiopulmonary restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiducial markers | Other | neoadjuvant or definitive chemoradiation |
| Fiducial markers, Pet and MRIInsertion of Fiducial markers in esophageal wall. | Other | neoadjuvant or definitive chemoradiation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Derived from this study: PubMed 32572560Vollenbrock 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.
- Individual participant dataSharing planned: Yes. data of two clinic trials will be joined for MRI scans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine Voncken, MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Chemoradiation, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify motion of the esophageal tumor over the course of chemoradiation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.