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NCT06247163 Clinical Trial

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

Small Cell Lung Carcinoma Clinical Trial

— PET-ART  

Official title:
Prospective PET-guided Radiotherapy for Patients With Small Cell Lung Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06247163
Other study ID # 23-11560-BO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2024
Est. completion date February 22, 2029

Study information
Verified date March 2024
Source University Hospital, Essen
Contact Maja Guberina
Phone 020172383121
Email maja.guberina@uk-essen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date February 22, 2029
Est. primary completion date February 22, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• PET based Raditherapy boost
An Interim PET CT will be performed. If there is residual vital tumor, a higher radiation dose will be applied.

Locations
Country Name City State
Germany University Hospital Essen Essen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local recurrence free survival Local recurrence free survival 2 months to 5 years
Primary Distant recurrence free survival Distant recurrence free survival 2 months to 5 years
Primary Overall survival Overall survival 2 months to 5 years
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