Standard Follow-Up Program (SFP) for Patients With Esopha... | NCT02454790

Studies
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer

NCT02454790

Sponsor

University Medical Center Groningen

Status

Recruiting

Last Update Posted

Feb 28, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Radiotherapy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

May 22, 2015

First Submission Date that Met QC Criteria

May 22, 2015

First Posted Date

May 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation			Chemoradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute toxicity		Highest during and within 2 weeks after last day of radiation therapy
Late toxicity		Highest within one year after last day of radiation therapy

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		At 1,2,3,4 and 5 years after first day of radiation therapy
Loco-regional tumor control		At 1,2,3,4 and 5 years after first day of radiation therapy

Other Outcomes

Measure	Description	Time Frame
Patient-rated symptoms and Quality-of-Life		Before first day of radiation therapy and at 3,6,12,24,36,48,60 months after first day of radiation therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with esophageal cancer
Patients receiving a radiotherapy dose > 40 Gy

Exclusion Criteria:

Failure to comply with any of the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with esophageal cancer receiving a radiotherapy dose > 40 Gy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CT Muijs, MD PhD	Contact	+31503615179		c.t.muijs@umcg.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen	Recruiting	Groningen		9700RB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D059248	Chemoradiotherapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D003131	Combined Modality Therapy
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided