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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237453
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborators:
University Hospital Tuebingen
Ludwig-Maximilians - University of Munich
German Cancer Research Center
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: Photons Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : June 23, 2022
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: MR-guided adaptive radiotherapy
Patients receive Photon radiotheray as an MR-guided adaptive radiotherapy
 Radiation: Photons
MR-guided adaptive radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. clinical feasibility -1- [ Time Frame: through study completion, an average of 2 years ]
    successfully completed online adapted RT fractions

  2. clinical feasibility -2- [ Time Frame: through study completion, an average of 2 years ]
    treatment time for online adapted RT fractions


Secondary Outcome Measures :
  1. acute side effects [ Time Frame: 3 months from treatment start ]
    changes in toxicity according to CTCAE V5.0

  2. subacute side effect [ Time Frame: 6 months from treatment start ]
    changes in toxicity according to CTCAE V5.0

  3. chronic side effect [ Time Frame: through study completion, at least 24 months ]
    changes in toxicity according to CTCAE V5.0

  4. Local tumor control [ Time Frame: through study completion, at least 24 months ]
    time from treatment start until in-field tumor recurrence

  5. Progession free survival [ Time Frame: through study completion, at least 24 months ]
    time from treatment start until death or progression of tumor disease

  6. Overall survival [ Time Frame: through study completion, at least 24 months ]
    time from treatment start until death

  7. Longitudinal pulmonary function [ Time Frame: through study completion, at least 24 months ]
    changes in forced exspiratory volume in 1st second (FEV1s), vital capacity (vc), etc.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-proven non-small cell lung cancer (NSCLC)
  • Stage III A - C according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification
  • Indication for definitive thoracic chemoradiotherapy
  • Age ≥ 18 years
  • ECOG 0 - 2
  • Adequate pulmonary function for chemoradiotherapy confirmed by a current pulmonary function test (≤ 6 weeks from treatment start)
  • Ability to lie still on the MR-linac table for at least one hour
  • Ability to hold one's breath for at least 20 seconds
  • Successful completion of an MR-guided treatment simulation
  • For women with childbearing potential: adequate contraception
  • Ability of the patient to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria:

  • Involvement of supraclavicular lymph nodes (supraclavicular N3)
  • Additional pulmonary lesions (T3 - 4 due to additional lesion in the same or another lobe)
  • Previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap
  • Patients who have not yet recovered from acute toxicities of prior therapies
  • Contraindications against performing MRI scans (e.g. pacemakers or other implants making MRI impossible)
  • Pregnant or lactating women
  • Participation in another competing clinical study or observation period of competing trials
  • Refusal of the patients to take part in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237453


Contacts
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Contact: Sebastian Regnery, MD +496221 56 ext 8201 sebastian.regnery@med.uni-heidelberg.de
Contact: Adriane Hommertgen, PhD +496221 56 ext 34091 adriane.hommertgen@med.uni-heidleberg.de

Locations
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Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Chiara De-Colle, Dr. med.         
Ludwig-Maximilian-Universität München Recruiting
Münich, Bayern, Germany, 81377
Contact: Stefanie Corradini, Dr.         
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Contact: Juliane Hörner-Rieber, Prof. Dr.         
Principal Investigator: Jürrgen Debus, Prof         
Sponsors and Collaborators
University Hospital Heidelberg
University Hospital Tuebingen
Ludwig-Maximilians - University of Munich
German Cancer Research Center
Investigators
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Principal Investigator: Juergen Debus, Prof University Hospital Heidelberg
More Information
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Responsible Party: Juergen Debus, Head of Department, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT05237453    
Other Study ID Numbers: RadOnk-PUMA_2021
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Debus, University Hospital Heidelberg:
lung cancer
adaptive Radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms