The Predictive Value of CT-PET in Esophageal Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02385604

Enrollment

250

Registered

2015-03-11

Start date

2014-01-31

Completion date

2016-01-31

Last updated

2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Positron-Emission Tomography, Neoadjuvant Therapy, Chemoradiotherapy, Esophagectomy, Response Evaluation Criteria in Solid Tumors, Treatment Outcome, Survival, Recurrence, Disease-Free Survival, Progression-Free Survival, Prognosis, Neoplasm Grading, Adenocarcinoma, Squamous Cell Carcinoma, Neoplasm Metastasis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival	Undetermined
Disease-free survival	Undetermined

Secondary

Measure	Time frame	Description
Histopathologic response	Undetermined	Mandard tumor regression grade, ypT, ypN stage

Countries

Ireland

Outcome results