PET-guided Radiotherapy for Patients With Small Cell Lung... | NCT06247163

Studies
PET-guided Radiotherapy for Patients With Small Cell Lung Cancer.

NCT06247163

Sponsor

University Hospital, Essen

Status

Recruiting

Last Update Posted

Sep 27, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Small Cell Lung Carcinoma

Interventions

PET based Raditherapy boost

Countries

Germany

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

Sep 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

Feb 22, 2024Actual

Primary Completion Date

Jun 22, 2025Estimated

Completion Date

Jun 22, 2029Estimated

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

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

Sep 25, 2024

Last Update Posted Date

Sep 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maja Guberina, PD Dr. med. (MD) Maja Guberina, specialist in radiation oncology, senior consultant, University Hospital, EssenPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society/Cancer Aid/AWMF

Detailed Description

The main objective of this study is to determine whether patients with SCLC who have a metabolically active residual tumor in the fluorodeoxyglucose (FDG) PET/CT scan after two to three cycles of induction chemotherapy have a similarly low local recurrence rate with higher dose. There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society/Cancer Aid/AWMF. Allocation to PET boost, if confirmed vital tumor rest by PET CT and biopsy.

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

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET based Raditherapy boost	Radiation	An Interim PET CT will be performed. If there is residual vital tumor, a higher radiation dose will be applied.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local recurrence free survival	Local recurrence free survival	2 months to 5 years
Distant recurrence free survival	Distant recurrence free survival	2 months to 5 years
Overall survival	Overall survival	2 months to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathologic confirmation
Limited disease

Exclusion Criteria:

Other histology than small cell lung cancer
Further tumor diagnosis
ECOG 3 or worse
Extensive disease
stage IV

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 confirmed diagnosis of small cell lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maja Guberina	Contact	020172383121		maja.guberina@uk-essen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Essen	Recruiting	Essen			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided