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

Surgical Resection Clinical Trial

Official title: A PHASE 2, SINGLE CENTRE, SINGLE ARM STUDY TO DETERMINE THE EFFICACY AND SAFETY OF 5- ALA POHOTODYNAMIC THERAPY AS ADJUVANT THERAPY AFTER SURGICAL DISSECTION IN PATIENTS WITH DESMOID TUMORS.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After
• Surgical Resection
• The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an

• NCT number: NCT01898416
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jacob Bickels, MD/PhD
• Phone: +972-524266341
• Email: jACOBB@TLVMC.GOV.IL
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2013
• Completion date: December 2026