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.
Who is this study for? Patients with Desmoid Tumor
What treatments are being studied? 5-AMINOLEVULINIC ACID
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Minimum Age: 18
Healthy Volunteers: No
• Patient has a resectable histologically confirmed desmoid tumor.
• Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
• Age > 18 years
• Signed informed consent prior to patient recruitment. -
Tel Aviv sourasky medical center
The Aviv Sourasky Medical Center
Jacob Bickels, MD/PhD
Start Date:June 2013
Estimated Completion Date:December 2026
Target number of participants:140
Experimental: 5-AminoLevulinicc Acid
consists of 60mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia and surgical tumor resection. Red light laser given by a Dye laser system, wave length of 635nm, in s dose of 150J/cm for 2000 seconds (33 minutes) will be given to tumor bed. In the case of positive margins (for tumor presence), a second surgical intervention followed by second 60mg/kg 5-ALA administration will be performed.