Defining the Radiotherapy Dose and Volume Parameters Affecting Postoperative Complications in Esophageal Cancer Patients

March 17, 2016 updated by: Maastricht Radiation Oncology

Correlation of Radiotherapy-related Features With Postoperative Complications in Patients With Esophageal Cancer Treated With Trimodality Therapy

The purpose of this study is to identify features of the cumulative dose-volume histogram (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery.

The investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (CROSS regimen 41,4 Gy in 23 fractions or 50, 4 Gy in 28 fractions ):

  • PTV volume1
  • MLD, V30, V20, V15, V10, VS5 (Volume lung less dan 5 Gy)2 (lung toxicity)
  • MHD, V20, V30, V403 (heart toxicity)
  • Mean stomach dose, V50 stomach
  • Mitochondrial DNA if available per patient Pre-existing cardiac,pulmonary comorbidity, smoking behavior, BMI, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. The investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. These latter data are already scored in a prospective manner at the Atrium Medical Center in Heerlen.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 ET
        • Maastro Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Oesophageal cancer patients who were initially treated with a preoperative dose of radiation in combination with chemotherapy and who subsequently underwent surgical resection at the Atrium Hospital in Heerlen. All patients were included in a prospectively maintained database.

Description

Inclusion Criteria:

  • Oesophageal cancer patients
  • initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection

Exclusion Criteria:

  • Patients who were treated with definitive chemoradiation or palliative radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: within 30 and 90 Days after operation

Cardiac complications (arrhythmia etc )

  • Respiratory complications (pneumonia, pleural effusion etc)
  • Anastomotic leakage
  • Postoperative 30-day mortality
  • Total postoperative mortality
  • Treatment-related mortality
  • Hospitalization and stay at intensive care unit duration
within 30 and 90 Days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-28-03/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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