About this trial

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.

Eligibility criteria

Qualifiers

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. -

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.

Treatment groups

140 Participants
are divided into 1 treatment group

Locations

2
Tel Aviv sourasky medical center64239, Tel AvivIsrael, Israel
The Aviv Sourasky Medical Center64239, Tel AvivIsrael, Israel

Sponsors and collaborators

michal roll

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution