Phase 2 Study of 5-ALA Oral and Laser Therapy After Surgery for Desmoid Tumors to Reduce Local Recurrence and Assess Safety

What this Trial Is About

Researchers are evaluating the effectiveness and safety of using 5-aminolevulinic acid 5-ALA oral administration combined with intraoperative photodynamic therapy as an additional treatment after surgical removal of desmoid tumors. The study is a phase 2, single-center, single-arm trial focused on reducing local tumor recurrence over three and five years in patients who have undergone surgery for these tumors. Participants receive 60 mgkg of 5-ALA solution orally 3 to 5 hours before anesthesia and tumor surgery. During surgery, a red light laser treatment at 635 nm wavelength is applied to the tumor bed for about 33 minutes at a dose of 150 Jcm. If tumor cells are detected at the margins, a second surgery with another dose of 5-ALA and laser treatment may be performed. Throughout the study, patients will be monitored for tumor recurrence at three and five years, and the safety of 5-ALA administration will be assessed. The main outcome is whether the tumor returns within three years after treatment. Participants will be followed closely with assessments to track safety and effectiveness over several years.

Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors