Esophageal NeoplasmsNCT02385604
The Predictive Value of CT-PET in Esophageal Cancer
An observational study of Esophageal Neoplasms, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- How many people
- 250 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2014to Jan 2016
- 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: Records for all patients with locally advanced esophageal and junctional tumors undergoing potentially curative multimodal therapy between November 2008 and November 2014 will be assessed.
Who may be able to join
- Locally advanced esophageal or junctional neoplasm
- Histologically confirmed adenocarcinoma or squamous cell carcinoma
- Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board
- CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study Center
- CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection
Who cannot join
- Incomplete data, patient lost to follow-up
- Scans performed at alternate Center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer
A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. The current gold standard for determining response to CRT is pathological evaluation following surgical resection, in particular the Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.The aim of this study is to determine the accuracy of CT-PET for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.
- Conditions
- Esophageal Neoplasms
- Keywords
- Positron-Emission Tomography, Neoadjuvant Therapy, Chemoradiotherapy, Esophagectomy, Response Evaluation Criteria in Solid Tumors, Treatment Outcome, Survival, Recurrence, Disease-Free Survival, Progression-Free Survival, Prognosis, Neoplasm Grading, Adenocarcinoma, Squamous Cell Carcinoma, Neoplasm Metastasis
- Medical subject headings
- Esophageal Neoplasms, Recurrence, Adenocarcinoma, Carcinoma, Squamous Cell, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Undetermined
Disease-free survival
Measured: Undetermined
Secondary outcomes (1)
Histopathologic response
Mandard tumor regression grade, ypT, ypN stage
Measured: Undetermined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jessie A Elliott, St. James's Hospital, Ireland
- Investigators
- John V Reynolds, MCh FRCS, Principal investigator, Department of Surgery, St. James's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385604
- Sponsor's protocol ID
- 12/009/2011
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Donohoe CL, O'Farrell NJ, Grant T, King S, Clarke L, Muldoon C, Reynolds JV. Classification of pathologic response to neoadjuvant therapy in esophageal and junctional cancer: assessment of existing measures and proposal of a novel 3-point standard. Ann Surg. 2013 Nov;258(5):784-92; discussion 792. doi: 10.1097/SLA.0b013e3182a66588.
PubMed 24045450Piessen G, Petyt G, Duhamel A, Mirabel X, Huglo D, Mariette C. Ineffectiveness of (1)(8)F-fluorodeoxyglucose positron emission tomography in the evaluation of tumor response after completion of neoadjuvant chemoradiation in esophageal cancer. Ann Surg. 2013 Jul;258(1):66-76. doi: 10.1097/SLA.0b013e31828676c4.
PubMed 23470576Elliott JA, O'Farrell NJ, King S, Halpenny D, Malik V, Muldoon C, Johnston C, Reynolds JV. Value of CT-PET after neoadjuvant chemoradiation in the prediction of histological tumour regression, nodal status and survival in oesophageal adenocarcinoma. Br J Surg. 2014 Dec;101(13):1702-11. doi: 10.1002/bjs.9670. Epub 2014 Oct 28.
PubMed 25351460
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02385604
- Acronym / sponsor ID
- 12/009/2011
- Conditions
- Esophageal Neoplasms
- Keywords
- Positron-Emission Tomography, Neoadjuvant Therapy, Chemoradiotherapy, Esophagectomy, Response Evaluation Criteria in Solid Tumors, Treatment Outcome, Survival, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Mar 2015 (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.
A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. The current gold standard for determining response to CRT is pathological evaluation following surgical resection, in particular the Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.The aim of this study is to determine the accuracy of CT-PET for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.
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
- Records for all patients with locally advanced esophageal and junctional tumors undergoing potentially curative multimodal therapy between November 2008 and November 2014 will be assessed.
Key inclusion criteria (5 listed)
- Locally advanced esophageal or junctional neoplasm
- Histologically confirmed adenocarcinoma or squamous cell carcinoma
- Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board
- CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study Center
- CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection
Key exclusion criteria (2 listed)
- Incomplete data, patient lost to follow-up
- Scans performed at alternate Center
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
Overall survival
Time frame: Undetermined
Disease-free survival
Time frame: Undetermined
1 secondary outcome
Histopathologic response
Time frame: Undetermined
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 10 Mar 2016.
- Background: PubMed 24045450Donohoe CL, O'Farrell NJ, Grant T, King S, Clarke L, Muldoon C, Reynolds JV. Classification of pathologic response to neoadjuvant therapy in esophageal and junctional cancer: assessment of existing measures and proposal of a novel 3-point standard. Ann Surg. 2013 Nov;258(5):784-92; discussion 792. doi: 10.1097/SLA.0b013e3182a66588.
- Background: PubMed 23470576Piessen G, Petyt G, Duhamel A, Mirabel X, Huglo D, Mariette C. Ineffectiveness of (1)(8)F-fluorodeoxyglucose positron emission tomography in the evaluation of tumor response after completion of neoadjuvant chemoradiation in esophageal cancer. Ann Surg. 2013 Jul;258(1):66-76. doi: 10.1097/SLA.0b013e31828676c4.
- Results publication: PubMed 25351460Elliott JA, O'Farrell NJ, King S, Halpenny D, Malik V, Muldoon C, Johnston C, Reynolds JV. Value of CT-PET after neoadjuvant chemoradiation in the prediction of histological tumour regression, nodal status and survival in oesophageal adenocarcinoma. Br J Surg. 2014 Dec;101(13):1702-11. doi: 10.1002/bjs.9670. Epub 2014 Oct 28.
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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.
John V Reynolds, MCh FRCS principal investigator
Department of Surgery, St. James's Hospital
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 Neoplasms, run by St. James's Hospital, Ireland at 1 site in Ireland.
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 5 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 10 Mar 2016. 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 Ireland. 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?
Overall survival (time frame: Undetermined). The study lists 2 primary outcomes in all. 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 NCT02385604, which also lists 3 linked publications.
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 10 Mar 2016.