Locally Advanced Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-small Cell Lung Canter Patients Unfit for concurrEnt RAdio-chemotherapy
This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereoractic ablative radiotherapy (SABR) in selected unresectable newly diagnosed and recurrent locally advanced (LA) non-small cell lung cancer (NSCLC) patients unfit for concurrent chemo-radiotherapy (ChT-RT). Patients unfit for concurrent ChT-RT but fit for chemotherapy will be enrolled to sequential ChT-SABR; patients unfit for ChT will be enrolled to exclusive SABR.
Current standard of care for fit patients with unresectable LA-NSCLC is concurrent chemo-radiotherapy (ChT-RT) which consists of 6 weeks of radiation and chemotherapy. Unfortunately many LA NSCLC patients, particularly the elderly, are unfit for concurrent ChT-RT because of their poor performance status and co-morbidities. Sequential ChT-RT and/or exclusive RT are options available for patients not suitable for concomitant approaches. Median progression-free survival among patients receiving concurrent ChT-RT is poor and no more than 15% of cases are alive at 5 years. This study is evaluating SABR in unresectable LA-NSCLC. Hypofractionated regimens of RT have emerged as a possible approach in LA-NSCLC, not only because prolonged treatments may discourage a proportion of elderly patients (20-30%) who are forced to give up treatment due to distance from the Radiotherapy Centre, but also for radiobiological reasons. Recent technological advances in RT, first of all stereotactic body radiotherapy (SBRT), have made hypofractionation widely applicable with the possibility to administer few (5 to 8) fractions of high external beam doses to the tumor, sparing the surrounding healthy tissues by a rapid fall of dose outside the target. LA-NSCLC patients will be discussed at the multidisciplinary lung cancer group and will be judged unfit for surgery and concurrent ChT-RT (e.g. elderly patients and/or large volume of disease and/or cardiovascular comorbidities) but suitable for RT. Neoadjuvant ChT will be evaluated case by case and will be prescribed only in fit patients. Starting from the standard radical conventionally administered dose for LA-NSCLC (equivalent to at least 54-60 Gy in 27-30 fractions), the investigators decided to prescribe an ablative dose of at least 35-40 Gy in 5 fractions. The SABR dose will be increased, case by case, respecting the maximum tolerance dose of healthy structures. The purpose of this study is to explore SABR in the treatment of unresectable LA-NSCLC. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT04013542 -
Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT03801902 -
Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), The ARCHON-1 Trial
|
Phase 1 | |
| Recruiting |
NCT05624996 -
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04227028 -
Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC
|
Phase 1 | |
| Recruiting |
NCT05166616 -
Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05269381 -
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06361784 -
Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS)
|
||
| Recruiting |
NCT05010109 -
Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
|
Phase 1 | |
| Recruiting |
NCT04751747 -
Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer
|
N/A | |
| Recruiting |
NCT05136846 -
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT04372927 -
ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy
|
Phase 2 | |
| Active, not recruiting |
NCT02595866 -
Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer
|
Phase 1 | |
| Recruiting |
NCT06349642 -
Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform
|