The Predictive Value of CT-PET in Esophageal Cancer

NCT ID: NCT02385604

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Incomplete data, patient lost to follow-up
* Scans performed at alternate Center
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. James's Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Dr Jessie A Elliott

Surgical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John V Reynolds, MCh FRCS

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, St. James's Hospital

Locations

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Department of Surgery, St. James's Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 24045450 (View on PubMed)

Piessen 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.

Reference Type BACKGROUND
PMID: 23470576 (View on PubMed)

Elliott 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.

Reference Type RESULT
PMID: 25351460 (View on PubMed)

Other Identifiers

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12/009/2011

Identifier Type: -

Identifier Source: org_study_id

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