NCT02323776

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

December 18, 2014

Last Update Submit

March 17, 2016

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    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

Interventions

Trimodality protocolOTHER

neoadjuvant chemoradiotherapy followed by surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients who were treated with definitive chemoradiation or palliative radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Philippe Lambin, MD, PhD

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations

NL(1)