Completed

RESPECTValue of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2009
See protocol details

Summary

Principal SponsorUniversity Medical Center Groningen
Last updated: March 23, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

This is a prospective cohort study testing the hypothesis that in a proportion of patients, locoregional recurrence, observed at 6, 12 or 18 months after treatment, can be prevented if PET/CT-based treatment planning was used instead of CT-based treatment planning alone. Patients eligible for the study will undergo definitive radiotherapy with or without concomitant chemotherapy with planning-CT based target volumes, either or not followed by surgery. A planning-PET/CT will be made for research purposes only, and will be blinded for the treating physicians. This planning-PET/CT will not be used for actual treatment planning. In case of neoadjuvant chemoradiation the response on this therapy will be analysed at pathologic evaluation of the esophageal specimen. Routine follow up will be carried out every 6 months, using CT. In case of no locoregional recurrence and/or metastases, patients will be followed up to 18 months for study evaluation. In case of distant metastases, patients will be censored if locoregional recurrence is excluded. When indicated, palliative treatment will be given. In case of (suspicion of) locoregional recurrence, PET/CT-based recurrence analysis should be carried out with comparison and co-registration of CT-based and PET/CT-based target volumes.

Principal SponsorUniversity Medical Center Groningen
Last updated: March 23, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteEsophageal Neoplasms

Criteria

5 inclusion criteria required to participate
Age >= 18 years

Locally curable disease without distant metastases (M1b is excluded) (TNM clinical classification UICC 7th edition)

Planned for high dose radiotherapy with or without chemotherapy with or without surgery

WHO performance status 0-2

Show More Criteria

3 exclusion criteria prevent from participating
Evidence of serious active infections

Previous treatment

any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

RISO

Deventer, NetherlandsOpen RISO in Google Maps

Medisch spectrum twente

Enschede, Netherlands

University Medical Center Groningen

Groningen, Netherlands
Completed3 Study Centers