drugset / Trial / NCT01898416

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

NCT01898416

Phase 2 Recruiting 140 enrolled michal roll
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.

Timeline

Start
2013-06
Primary completion
2023-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 60 mg/kg Oral