The Predictive Value of CT-PET in 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.

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Key information

Conditions

Esophageal Neoplasms Adenocarcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Disease Attributes Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, St. James's Hospital

Dublin, D4, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Overall survival

Time frame: Undetermined
Disease-free survival

Time frame: Undetermined

Secondary outcomes

Histopathologic response

Time frame: Undetermined

Mandard tumor regression grade, ypT, ypN stage

Sponsors and collaborators

Lead sponsor

St. James's Hospital, Ireland

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 11, 2015
Registry last updated: Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed