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

JRCT ID: jRCT2031200040

Registered date:01/06/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Peripheral Lung Cancer
• Date of first enrollment: 03/06/2020
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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)).

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival,Cancer-related survival,Local control effect

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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 the study.

Exclude criteria

1)Patients with target lesions detected by high-resolution chest computed tomography that have a maximal diameter of the enhancing component (enhancing component diameter) that is less than or equal to 25% of the total lesion diameter.
2)Patients with active multiple cancers (simultaneous multiple cancers/multiple cancers and heterogeneous multiple cancers/multiple cancers with a disease-free period of 5 years or less)
However, even if the disease-free period is less than 5 years, clinical stage I lung cancer is not included in multiple cancers and can be included. In addition, a history of clinical stage I prostate cancer and complete resection of the following stage cancers are not included as active duplicate cancers.
3)Female patients who are pregnant or potentially pregnant, female patients who are lactating, female patients who wish to become pregnant by the end of the study observation period, or male patients whose partner wishes to become pregnant.
4)Patients who are unable to use an appropriate contraceptive method (e.g., condoms, pessaries, etc.) or cannot obtain appropriate contraceptive consent from the time consent is obtained until the completion of the observation period of this study.
5)Patients with advanced cardiac, hepatic, renal, gastrointestinal, hematological, endocrine, neurological, or psychiatric disorders.
6)Patients with a history of or concomitant photosensitivity.
7)Patients with concomitant porphyria.
8)Patients participating in other clinical trials or specific clinical research.
9)Other patients deemed inappropriate as the subject of the clinical trial by the investigator or investigator-supplier.

Related Information

• Primary Sponsor: Usuda Jitsuo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED),Meiji Seika Pharma Co.,Ltd