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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323776
• Other study ID #: 14-28-03/09
• Status: Terminated
• Phase: N/A
• First received: December 18, 2014
• Last updated: March 17, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Postoperative Complications

Intervention

Other:
• Trimodality protocol
neoadjuvant chemoradiotherapy followed by surgery

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No