Clinical trial NCT02385604: The Predictive Value of CT-PET in Esophageal Cancer
Official title: CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Records for all patients with locally advanced esophageal and junctional tumors undergoing potentially curative multimodal therapy between November 2008 and November 2014 will be assessed.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Undetermined
measure: Disease-free survival
timeFrame: Undetermined
Secondary outcomes:
measure: Histopathologic response
timeFrame: Undetermined
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Department of Surgery, St. James's Hospital
Study officials:
affiliation: Department of Surgery, St. James's Hospital
name: John V Reynolds, MCh FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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 Surg. 2014 Dec;101(13):1702-11. doi: 10.1002/bjs.9670. Epub 2014 Oct 28.