C78.0 C34 C80
Conditions
Interventions
Group 1: Patients will be recruited into five cohorts comprising the following radiation doses to the targeted tumour-containing lung segment(s):
Cohort 1: 38Gy
Group 2: Cohort 2: 44 Gy
Group 3: Cohor
Sponsors
LMU Klinikum; Ärztliche Direktion
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. willing, able and mentally competent to give informed written consent 2. at the age of 18 years or older 3. histologically proven primary carcinoma of any origin (except the central nervous system and lung) with lung metastases or primary non-small-cell lung carcinoma (Note: HCC patients can be admitted without histology according to the current guidelines) 4. clear and measurable CT detection of either lung metastases of primary carcinoma or primary non-small cell lung cancer 5. stage IV in oligometastatic lung disease Condition that is not suitable for treatment by surgical resection, local ablation, radiotherapy or other conventional techniques and is either unsuitable or in which all conventional systemic treatment options such as chemotherapy, immunotherapy or targeted therapy have failed. The determination that all available "standard of care" treatment options are no longer appropriate must be made by the Tumour Board (OSTB) responsible for patient treatment. The oncological justification must be documented accordingly. Note: A combination of local therapy (surgery, ablation, radiation) and SIRT is acceptable under this protocol if the OSTB deems it appropriate. Pulmonary SIRT and other local procedures are performed as sequential procedures. The remaining total lung volume of all procedures shall not be less than 60%. Note: Measurable disease is defined as lung lesions that can be accurately measured in at least one dimension with the longest diameter =10mm using CT. 6. suitable for protocol therapy determined by a multidisciplinary team, e.g. an interventional radiologist, thoracic surgeon, pulmonologist, medical oncologist and radio-oncology investigator 7. all imaging evidence used in the screening process must be less than 30 days old or the same age at the time of entry into the study 8. in the case of a previous systemic anti-tumour treatment, a washout window of at least 45 days after completion of the previous therapy and start of SIRT treatment was observed to exclude any interaction of the local irradiation with any remaining previous medical treatment The multidisciplinary team can recommend an extension of the washout window. 9 WHO performance status 0 - 2 10. adequate haematological and renal function as follows: Haematological neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Haemoglobin > 10 g/dL Renal creatinine < 1.5 x ULN Note: Blood results must be less than 7 days old at the time of study entry. 11. patients must be either postmenopausal, sterile (surgically or by irradiation or chemically induced) or - in the case of sexual activity - using a highly effective contraceptive method (failure rate < 1% / year) 12. male patients must be surgically sterile or, if they are sexually active and have a premenopausal partner, use an acceptable method of contraception 13. estimated life expectancy of at least 3 months without active treatment
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. manifest respiratory insufficiency, defined as: pO2 45mm Hg 2. previous radiotherapy in the target region 3. suitable for treatment by surgical resection, taking into account the following criteria of functional resectability a. FEV1 at least 30% of predicted normal value; and/or b. Diffusion capacity at least 30 % of the predicted normal value; and/or c. Maximum O2 uptake with ergospirometry at least 15mL/min/kg, and/or d. EF at least 30% on echocardiography 4. intercurrent disease that would make the patient unfit for treatment under this Clinical Trial Plan, such as, but not limited to bronchial asthma (bronchial asthma, that cannot be treated adequately), severe chronic obstructive pulmonary disease (COPD), restrictive pulmonary disease, pulmonary hypertension with PAPsys =35 mmHG on echocardiography 5. uncontrolled cardiovascular disease presently or within the last 6 months (e.g. myocardial infarction, unstable angina pectoris, uncontrolled congestive heart failure, significant uncontrolled cardiac arrhythmia or conduction disorders, heart valve disease with significant impairment of heart function or insufficiently controlled hypertension) 6. history or current presence of deep vein thrombosis 7. any lung tumour that extends beyond the lung parenchyma, e.g. involvement of mediastinal structures, chest wall or pleura (pleural carcinosis) 8. primary cancers of the central nervous system (CNS) or CNS metastases 9. ambiguous, non-measurable or non-evaluable pulmonary metastases from a primary carcinoma; or primary non-small cell lung carcinoma as the only detection of lung lesions 10. known allergies to contrast media used in the study (e.g. iodinated angiographic contrast media, F-18 FDG or 99mTc-MAA) 11. previous SIRT treatment 12. pregnant or breastfeeding mother 13. currently participating in an active part of another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Pulmonary SIRT will be regarded as feasible if the first dose level can be completed without reaching dose-limiting toxicity in more than 1/3 patients or imminent stasis in more than 3/6 patients. A patient is regarded to have reached imminent stasis if more than 50% of targeted segment/s present with imminent stasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and toxicity (Patient safety and toxicity should be monitored from the time of informed consent until 60 months after SIRT. Tumor response rate (Response across all lung lesions is determined using adapted criteria for assessing response in solid tumors version 1.1 (RECIST 1.1). Quality of Life: The Functional Assessment of Cancer Therapy - Lung (FACT-L), developed by the American Thoracic Society, is a tool for assessing the quality of life of lung cancer patients. The questionnaire comprises 5 subscores (physical, social/family, emotional, functional well-being and lung cancer subscale (symptoms, cognitive function, regret of smoking). | — |
Countries
Germany
Contacts
Public ContactManuela Estermann
LMU Klinikum; Klinik und Poliklinik für Radiologie
Outcome results
None listed