The Predictive Value of CT-PET in Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385604
• Other study ID #: 12/009/2011
• 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

• Esophageal Neoplasms

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

External Links

•   Department of Surgery