SDC for Lung Cancer Patients Treated With Curative Primar... | NCT01855191

Studies
SDC for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation

NCT01855191

Sponsor

Maastricht Radiation Oncology

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

864Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013Actual

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

May 15, 2013

First Posted Date

May 16, 2013Estimated

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

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

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

Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

Detailed Description

All patients planned for curative primary or postoperative radiotherapy can be included. Patients will be treated according to the institutional protocol. It is optional to collect a saliva sample for genetic profiling.

Follow up at five time points:

2 weeks after RT
3 months after RT
6 months after RT
12 months after RT
24 months after RT

At these time points, toxicity will be assessed. In addition, patients will receive a short questionnaire by mail at eight time points.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

864Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Two-year survival rate		24 months after RT

Secondary Outcomes

Measure	Description	Time Frame
Change in dyspnea		during 24 months after RT
Change in cough		During 24 months after RT
Change in dysphagia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients planned for curatively intended radiotherapy or postoperative radiotherapy
Recurrent disease

Exclusion Criteria:

All patients planned for palliative radiotherapy

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

All patients planned for curatively intended radiotherapy or postoperative radiotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dirk De Ruysscher, MD., PhD.	Maastro Clinic, The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MAASTRO clinic		Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided