The Predictive Value of CT-PET in Esophageal Cancer

Overview

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.

Full Title of Study: “CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2016

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: Undetermined
  • Disease-free survival
    • Time Frame: Undetermined

Secondary Measures

  • Histopathologic response
    • Time Frame: Undetermined
    • Mandard tumor regression grade, ypT, ypN stage

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. James’s Hospital, Ireland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Jessie A Elliott, Surgical Research Fellow – St. James’s Hospital, Ireland
  • Overall Official(s)
    • John V Reynolds, MCh FRCS, Principal Investigator, Department of Surgery, St. James’s Hospital

References

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.

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.

Citations Reporting on Results

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.

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