Trials / Recruiting
RecruitingNCT01898416
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
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- michal roll · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- The 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. | 60 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. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2023-12-01
- Completion
- 2026-12-01
- First posted
- 2013-07-12
- Last updated
- 2013-10-31
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT01898416. Inclusion in this directory is not an endorsement.