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

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

Sponsormichal roll

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

Sponsors and collaborators

michal roll

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution

Source ClinicalTrials.gov