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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02385604
Other study ID # 12/009/2011
Secondary ID
Status Completed
Phase N/A
First received March 2, 2015
Last updated March 9, 2016
Start date January 2014
Est. completion date January 2016

Study information

Verified date March 2016
Source St. James's Hospital, Ireland
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Ireland Department of Surgery, St. James's Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View Citation

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 — View Citation

Piessen G, Petyt G, Duhamel A, Mirabel X, Huglo D, Mariette C. Ineffectiveness of ¹8F-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Undetermined No
Primary Disease-free survival Undetermined No
Secondary Histopathologic response Mandard tumor regression grade, ypT, ypN stage Undetermined No
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