Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients receive Photon radiotheray as an MR-guided adaptive radiotherapy

Photons

Sebastian Regnery, MD

Adriane Hommertgen, PhD

Chiara De-Colle, Dr. med.

Stefanie Corradini, Dr.

Juliane Hörner-Rieber, Prof. Dr.

Jürrgen Debus, Prof

Juergen Debus, Prof

MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such individualized treatment approaches can lead to reduced toxicity and potentially better local tumor control for patients with LA-NSCLC in the future. PUMA is an early clinical trial, which aims to demonstrate the feasibility of MR-guided online ART to locally-advanced NSCLC. In a second step, the investigators aim to use the data from this feasibility trial to design and launch a further phase I/II clinical study that directly compares the benefits of MR-guided online ART of LA-NSCLC to CT-based (A)RT approaches.

Non-small cell lung cancer (NSCLC) is very common and carries the highest mortality of all malignant diseases (350.000 - 400.000 deaths per year in the European Union). In specific, the 5-year overall survival rate of locally-advanced NSCLC (LA-NSCLC) is merely 20%. One reason for this dismal prognosis is the lack of effective treatment options. Since most patients with LA-NSCLC are not candidates for a tumor resection, definitive (chemo)radiotherapy (C)RT with consecutive immunotherapy (IT) is the treatment of choice according to national and international guidelines. However, local tumor relapse remains a major pattern of recurrence in approx. 30% of cases. Furthermore, many patients cannot benefit from chemotherapy due to multiple comorbidities, and application of IT requires an initial tumor response to (C)RT and absence of higher-grade pulmonary toxicity. Consequently, radiotherapy is a cornerstone in the locally ablative treatment of LA-NSCLC and essentially influences the course of the further treatment. MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such adaptive radiation approaches allow highly individualized thoracic radiotherapy with dose distributions tailored to the interfractional changes in tumor geometry and anatomy of surrounding OARs. Therefore, MR-guided ART has the potential to optimize the balance between intensified target volume dose and sparing of vulnerable OARs. This prospective, multicenter clinical trial is desinged to demonstrate the clinical feasibility and gain first data on the safety of MR-guided online ART to LA-NSCLC. Based on the investigators extensive experience with MR-guided RT of early-stage NSCLC and lung metastases, the invesitgators hypothesize that MR-guided online ART to LA-NSCLC can be performed successfully in ≥ 80% of patients with a mean time \< 90 minutes. The investigators plan to include 30 patients with LA-NSCLC in Union for International Cancer Control (UICC) stage IIIA-C at three German university hospitals (Uniklinikum Heidelberg, Uniklinikum LMU München, Uniklinikum Tübingen). Patients will receive MR-guided online ART, which includes gated dose delivery as well as online plan adaptation once weekly or in case major anatomical changes are detected on daily MR-imaging. Patients will be followed-up to assess toxicity, tumor control (by means of thoracic CT- and MR-imaging) and patient-reported outcomes for 24 months after treatment.

Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer

successfully completed online adapted RT fractions

treatment time for online adapted RT fractions

changes in toxicity according to CTCAE V5.0

time from treatment start until in-field tumor recurrence

time from treatment start until death or progression of tumor disease

changes in forced exspiratory volume in 1st second (FEV1s), vital capacity (vc), etc.

University Hospital Tuebingen

Ludwig-Maximilians - University of Munich

German Cancer Research Center

University Hospital Heidelberg

Head of Department

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Behaviors and Mental Disorders

Rare Diseases

Tonsillar Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Quality of Life

Acute Graft Versus Host Disease

Radiotherapy with either photons or protons.

Radiotherapy

Maria Gebre-Medhin, MD

Iréne Schönström, RN

Ann-Sofie Fransson, MD

Hedda Haugen, MD

Mattias Olin, MD

Britta Lödén, MD

Anna Flejmer, MD

Michael Gubanski, MD

Björn Zackrisson, MD

Johanna Färlin, MD

Zahra Taheri Kadkhoda, MD

Zizana Lovasova, MD

Zuzana Lovasova, MD

Erik Lundin, MD

In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0

Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.

Lund University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer	NCT05237453	Non-small Cell ...	Photons	18 Years -	University Hospital Heidelberg
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.	NCT03829033	Tonsil Cancer	Radiotherapy	18 Years -	Lund University Hospital

Spots Global Cancer Trial Database for photons

Every month we try and update this database with for photons cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for photons

Every month we try and update this database with for photons cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for photons cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.