PET-Plan - Optimization of radiotherapy planning in patients with inoperable locally advanced NSCLC using F-18-FDG-PET

Not Applicable

Completed

• Conditions: C34; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00002178
• Lead Sponsor: Klinik für Strahlenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-24
• Study Completion: 2017-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Written informed Consent.
Histologically proven NSCLC, UICC-stage II-III.
Resection planned according to interdisciplinary consensus.
Complete staging < 6 weeks before initiation of treatment including cranial MRI or, if not possible, cranial CT.
ECOG < 3, Karnofsky-Index > 60%.
Age > 18 years. FEV1 > 1,0 l or >35% of expected value.
RT-planning according to both protocol arms feasible.
Application of chemotherapy feasible according to the treating study center specific standards.

Exclusion Criteria

Neuroendocrine tumors or broncho-alveolar-cell carcinoma.
Distant metastases, supraclavicular lymph node metastases.
Malignant pleural or pericardial effusion.
Acute superior vena cava syndrome.
Recent pulmonary resection of the present NSCLC.
Parallel participation in another clinical trial. Chemotherapy or targeted therapy for to present NSCLC before study inclusion.
Induction chemotherapy.
Second malignancy (other than basalioma) within 2 years of study inclusion.
Pregnancy or lactation.
Application of chemotherapy not possible according to study center institutional standards.
Heart insufficiency NYHA III/IV.
FDG-PET associated exclusion criteria:
Detection of distant metastases or a secondary malignancy. Downstaging or change of therapeutical concept.
Acute broncho-pulmonary infection at time of the FDG-PET acquisition.
Active inflammatory changes of mediastinal lymph nodes associated with pneumoconiosis, sarcoidosis or tuberculosis.
FDG-PET acquisition not in radiotherapy planning position.
Co-registration of FDG-PET and CT not according to protocol guidelines.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to locoregional progression.

Secondary Outcome Measures

Name	Time	Method
Rate of acute and late normal tissue toxicity. <br>Overall survival (inten-to-treat). <br>Progression free survival including progression in and out of the irradiaton field as well as distant failures. <br>Rate of mediastinal in- and out field failures. <br>Total PTV reference dose and PTV volumes in the study arms.