Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)NCT01269970
Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy
An observational study of Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
- What is being tested?
- 18-FDG-PET-CT
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Jan 2004to Dec 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: locally advanced esophageal cancer (cT2-4 N0/+) of the esophagus (n=42) and GEJ (n=13)
Who may be able to join
- locally advanced esophageal cancer (cT2-4 N0/+)
Who cannot join
- PET-CT not performed at UZLeuven
- Other tumor types
- Distant metastases (organ)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Metabolic Response Evaluation With 18-FDG PET-CT in Esophageal Cancer Treated With Neoadjuvant Chemoradiotherapy Followed by Esophagectomy
Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer treated by neoadjuvant CRT and esophagectomy.
- Being tested
- 18-FDG-PET-CT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-FDG-PET-CTOther
| Study group | Role | What they receive |
|---|---|---|
| locally advanced esophageal carcinoma (cT2-3N0/+) | Not described Receives: Other: 18-FDG-PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
early metabolic response to predict pathological response and outcome
assess the value of early metabolic response with 18-FDG-PET-CT (i.e. a decrease of ≥ 35% of SUVmean) after a single cycle of chemotherapy followed by neoadjuvant CRT and esophagectomy as a tool to predict pathological response and outcome in patients with cT2-4N0/+ carcinoma of the esophagus and GE-junction (GEJ).
Secondary outcomes (1)
to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2004
- Primary completionJul 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269970
- Sponsor's protocol ID
- G.0175.03
- Other IDs
- S24640
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Metabolic Response Evaluation With 18-FDG PET-CT in Esophageal Cancer Treated With Neoadjuvant Chemoradiotherapy Followed by Esophagectomy
- ClinicalTrials.gov ID
- NCT01269970
- Acronym / sponsor ID
- G.0175.03
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jan 2011 (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.
Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer treated by neoadjuvant CRT and esophagectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| locally advanced esophageal carcinoma (cT2-3N0/+) | – | Other: 18-FDG-PET-CT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- locally advanced esophageal cancer (cT2-4 N0/+) of the esophagus (n=42) and GEJ (n=13)
Key inclusion criteria (1 listed)
- locally advanced esophageal cancer (cT2-4 N0/+)
Key exclusion criteria (3 listed)
- PET-CT not performed at UZLeuven
- Other tumor types
- Distant metastases (organ)
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 |
|---|---|---|
| 18-FDG-PET-CT | Other | locally advanced esophageal carcinoma (cT2-3N0/+) |
Primary outcome
early metabolic response to predict pathological response and outcome
assess the value of early metabolic response with 18-FDG-PET-CT (i.e. a decrease of ≥ 35% of SUVmean) after a single cycle of chemotherapy followed by neoadjuvant CRT and esophagectomy as a tool to predict pathological response and outcome in patients with cT2-4N0/+ carcinoma of the esophagus and GE-junction (GEJ).
1 secondary outcome
to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.
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 4 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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 4 Jan 2011. 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 Belgium. 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?
early metabolic response to predict pathological response and outcome. 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 4 Jan 2011.