Esophageal NeoplasmsNCT01156831
PET-CT Based Radiotherapy in Esophageal Cancer Patients
An observational study of Esophageal Neoplasms, run by Maastricht Radiation Oncology at 5 sites in Netherlands.
Trial summary
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- How many people
- 115 participants
- Where
- 5 sitesNetherlands
- Study dates
- Nov 2007to May 2013
- 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: Primary Care Clinic
Who may be able to join
- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
- Local curable disease able to undergo Chemoradiotherapy.
Who cannot join
- Metastasized disease.
- Previous or concurrent malignancies.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Atrium Hospital
Heerlen
University Medical Center
Maastricht
St. Laurentius Hospital
Roermond
Maasland Hospital
Sittard
St. Jansgasthuis
Weert
About this study
Official title: Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.
Read the detailed description
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal cancer, PET-CT planning
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
Measured: 2 years and 5 years
Secondary outcomes (3)
Overall Survival
Measured: 2 years and 5 years
Disease Free survival
Measured: 2 years and 5 years
Tumor regression grade
Tumor regression grade at time of surgery evaluated by pathologist.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startNov 2007
- Primary completionMay 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Lammering, MD PhD, Principal investigator, Radiation Oncology, Maastro ClinicMeindert Sosef, MD PhD, Principal investigator, Atrium Hospital Heerlen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156831
- Sponsor's protocol ID
- 09-18-12/08
- Status last verified
- Dec 2014
- First submitted
- 2 Jul 2010
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT01156831
- Acronym / sponsor ID
- 09-18-12/08
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal cancer, PET-CT planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jul 2010 (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.
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.
Detailed description
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
- Local curable disease able to undergo Chemoradiotherapy.
Key exclusion criteria (2 listed)
- Metastasized disease.
- Previous or concurrent malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Locoregional control
Time frame: 2 years and 5 years
3 secondary outcomes
Overall Survival
Time frame: 2 years and 5 years
Disease Free survival
Time frame: 2 years and 5 years
Tumor regression grade
Time frame: At the time of surgery
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 8 Dec 2014.
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Guido Lammering, MD PhD principal investigator
Radiation Oncology, Maastro Clinic
Meindert Sosef, MD PhD principal investigator
Atrium Hospital Heerlen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by Maastricht Radiation Oncology at 5 sites 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 2 inclusion and 2 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Locoregional control (time frame: 2 years and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2014.