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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01898416|
Recruitment Status : Recruiting
First Posted : July 12, 2013
Last Update Posted : October 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2026|
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.
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.
- 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 [ Time Frame: three years ]
- To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate. [ Time Frame: five years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898416
|Contact: Jacob Bickels, MD/PhD||+972-524266341||jACOBB@TLVMC.GOV.IL|
|Tel Aviv sourasky medical center||Recruiting|
|Tel AVIV, Israel, 64239|
|Contact: Jacob Bickels, MD/PhD +972-524266341 JACOBB@TLVMC.GOV.IL|
|The Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Jacob Bickels, MD/PhD +972-524266341 email@example.com|
|Principal Investigator: Jacob Bickels, MD/PhD|
|Principal Investigator:||Jacob Bickels, MD/PhD||Tel-Aviv Sourasky Medical Center|