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.
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. -
Hepatic enzymes or bilirubin > 2X upper limit of normal.
Serum creatinine > 2.5 x upper limit of normal.
Suspected /documented metastatic disease.
Active or uncontrolled infections.
Single group
5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
Drug60 mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia. 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 case of positive margins a second operation and 5-ALA administration or irradiation will be given.
The primary endpoint is a binary variable where each patient is classified as a recurrence or a not recurrence case and will be determined by calculating the proportion of recurrence versus non recurrence rates
To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
Data from all subjects who receive any study drug will be included in the safety analyses. The severity of the toxicities will be graded according to the NCI CTCAE whenever possible. Adverse events will be summarized by worst NCI CTC grade. Adverse events classified as NCI CTCAE Grade 3 or Grade 4, study-drug-related events, and serious adverse events will be summarized separately. Laboratory data will be graded according to NCI CTCAE severity grade.
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michal roll
Lead sponsor
Tel-Aviv Sourasky Medical Center
Sponsor institution
