NCT06247163

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
38mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2024Jun 2029

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2029

Expected
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

January 30, 2024

Last Update Submit

September 25, 2024

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

PET based Raditherapy boostRADIATION

An Interim PET CT will be performed. If there is residual vital tumor, a higher radiation dose will be applied.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed diagnosis of small cell lung cancer

You may qualify if:

  • Histopathologic confirmation
  • Limited disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, Germany

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Maja Guberina

CONTACT

020172383121maja.guberina@uk-essen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. (MD) Maja Guberina, specialist in radiation oncology, senior consultant

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

February 22, 2024

Primary Completion

June 22, 2025

Study Completion (Estimated)

June 22, 2029

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)