Status:
RECRUITING
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
Lead Sponsor:
michal roll
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
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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.
- Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
- Use of other investigational agents \< 30 days prior to the study.
- Patients who are mentally or physically unable to comply with all aspects of the study.
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females.
- Known intolerance or allergy to 5-ALA
- Suspicious or documented acute or chronic porphyria
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01898416
Start Date
June 1 2013
End Date
December 1 2026
Last Update
October 31 2013
Active Locations (2)
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1
Tel Aviv sourasky medical center
Tel Aviv, Israel, Israel, 64239
2
The Aviv Sourasky Medical Center
Tel Aviv, Israel, Israel, 64239