A randomized controlled trial of best supportive care (BSC) versus photodynamic therapy with ME2906 and PNL6405PLC for patients with peripheral lung cancer

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: PDT group: Add 4 ml of daily saline solution to 1 vial of ME2906, stir well, and inject 40 mg/m2 of dissolved solution intravenously once. Four to six hours after the administration, the cyndlical type laser probe is introduced to the lesion and the lesion is irradiated using a PNL6405 PLC. Thereafter, patients will be observed until the study is completed or the discontinuation criteria are met. BSC group: No treatment and observation until the end of the study or until the discontinuation criteria are met. However, in the case of exacerbation, PDT can be performed (salvage PDT (S‐PDT)). CONDITION: D002289 Peripheral Lung Cancer ; Lung Cancer PRIMARY OUTCOME: Progression‐free survival SECONDARY OUTCOME: Overall survival,Cancer‐related survival,Local control effect INCLUSION CRITERIA: 1)Patients aged 40 years or older at the time of obtaining consent. 2)Patients with non‐small cell lung cancer as defined in the 8th edition of general rule for clinical and pathological record of lung cancer 3)Patients with stage IA clinical disease as defined in the 8th edition of general rule for clinical and pathological record of lung cancer. No prior treatment is required. 4)Patients in whom the target lesion detected by high‐resolution computed tomography (CT) is distal to the ipsilateral subregional branch and the maximum diameter of the entire lesion (total lesion diameter) is less than or equal to 25 mm. 5)Patients who can be diagnosed and treated using bronchoscopy. 6)Patients not indicated for surgery. 7)Patients not indicated for radiation therapy. 8)Patients with a US East Coast Cancer Clinical Trials Group (ECOG) General Status (PS) score of 0, 1, or 2. 9)Patients who obtain written consent from the patient to participate in th
Epistemonikos ID: c13727072e16949a747eb1392c75ec19cf72307b
First added on: Aug 24, 2024