Accelerated Immuno Chemoradiotherapy Based on FDG-PET/CT for Small Volume in Locally Advanced NSCLC (PACCELIO) – A Phase II Multicenter Randomized Open-Label Trial Protocol - Scorecard - MDSpire
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Accelerated Immuno Chemoradiotherapy Based on FDG-PET/CT for Small Volume in Locally Advanced NSCLC (PACCELIO) – A Phase II Multicenter Randomized Open-Label Trial Protocol
Clinical Scorecard: Accelerated Immuno Chemoradiotherapy Based on FDG-PET/CT for Small Volume in Locally Advanced NSCLC (PACCELIO) – A Phase II Multicenter Randomized Open-Label Trial Protocol
At a Glance
Category
Detail
Condition
Locally advanced (stage III) non-small cell lung cancer (NSCLC)
Key Mechanisms
Concurrent or sequential chemoradiation (CRT) followed by consolidation immunotherapy with durvalumab; FDG-PET/CT guided radiotherapy target volume definition; hypofractionated accelerated radiotherapy
Target Population
Patients with unresectable locally advanced NSCLC, particularly with small volume disease suitable for FDG-PET/CT based radiotherapy planning
Care Setting
Multicenter oncology centers providing chemoradiotherapy and immunotherapy
Key Highlights
Durvalumab consolidation after CRT improves tumor control and survival but up to 50% of patients do not proceed due to progression or toxicity.
FDG-PET/CT integration allows precise gross tumor volume delineation, reducing irradiation of uninvolved lymph nodes and improving locoregional control without increased out-field recurrences.
Hypofractionated accelerated radiotherapy may reduce treatment duration and toxicity, potentially increasing patient compliance and eligibility for consolidation immunotherapy.
Guideline-Based Recommendations
Diagnosis
Use FDG-PET/CT imaging for accurate radiotherapy target volume definition in stage III NSCLC.
Management
Administer concurrent or sequential chemoradiation (cisplatin-based) followed by consolidation immunotherapy with durvalumab in unresectable stage III NSCLC.
Consider hypofractionated accelerated radiotherapy schedules to reduce treatment duration and toxicity.
Monitoring & Follow-up
Monitor systemic inflammation biomarkers such as neutrophil-lymphocyte ratio (NLR) and advanced lung cancer inflammation index (ALI) for prognosis and treatment response prediction.
Risks
CRT-related toxicity affecting heart, lungs, and esophagus may limit treatment escalation and consolidation immunotherapy eligibility.
Approximately 45% of patients progress or die within one year after starting consolidation durvalumab.
Patient & Prescribing Data
Patients with unresectable stage III NSCLC undergoing CRT and consolidation immunotherapy
Real-world data show 50–68% transition rates to durvalumab consolidation; hypofractionated CRT may improve compliance and reduce attrition before immunotherapy.
Clinical Best Practices
Incorporate FDG-PET/CT for precise radiotherapy planning to limit radiation to involved tumor and lymph nodes only.
Use cisplatin-based chemotherapy concurrently or sequentially with radiotherapy to enhance radiosensitization.
Apply hypofractionated accelerated radiotherapy regimens to shorten treatment duration and potentially improve outcomes.
Assess systemic inflammation markers (NLR, ALI) to aid prognosis and tailor treatment strategies.
Streamline treatment pathways to maximize patient eligibility for consolidation immunotherapy.
by Rami El Shafie, Jonas Willmann, Eleni Gkika, Tanja Schimek-Jasch, Matthias Miederer, Farastuk Bozorgmehr, Frank Griesinger, Farkhad Manapov, Petros Christopoulos, Thomas Hehr, Markus Hecht, Rebecca Bütof, Martin Stuschke, Matthias Guckenberger, Gerald Schmid-Bindert, Jan Meiners, Sascha Herzer, Sonja Hartmann, Joana Lamché, Stefan Rieken, Ursula Nestle
