Non-small Cell Lung Cancer Clinical Trial
— PUMAOfficial title:
Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2027 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Heidelberg, Radiation Oncology | Heidelberg | |
Germany | Ludwig-Maximilian-Universität München | Münich | Bayern |
Germany | Universitätsklinikum Tübingen | Tübingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg | German Cancer Research Center, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical feasibility -1- | successfully completed online adapted RT fractions | through study completion, an average of 2 years | |
Primary | clinical feasibility -2- | treatment time for online adapted RT fractions | through study completion, an average of 2 years | |
Secondary | acute side effects | changes in toxicity according to CTCAE V5.0 | 3 months from treatment start | |
Secondary | subacute side effect | changes in toxicity according to CTCAE V5.0 | 6 months from treatment start | |
Secondary | chronic side effect | changes in toxicity according to CTCAE V5.0 | through study completion, at least 24 months | |
Secondary | Local tumor control | time from treatment start until in-field tumor recurrence | through study completion, at least 24 months | |
Secondary | Progession free survival | time from treatment start until death or progression of tumor disease | through study completion, at least 24 months | |
Secondary | Overall survival | time from treatment start until death | through study completion, at least 24 months | |
Secondary | Longitudinal pulmonary function | changes in forced exspiratory volume in 1st second (FEV1s), vital capacity (vc), etc. | through study completion, at least 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |