Actively 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
Led by michal roll · Updated on 2013-10-31
140
Participants Needed
2
Research Sites
704 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Hepatic enzymes or bilirubin > 2 times upper limit of normal.
- Serum creatinine > 2.5 times upper limit of normal.
- Suspected or documented metastatic disease.
- Active or uncontrolled infections.
- Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) within 2 years prior to the study.
- Use of other investigational agents within 30 days prior to the study.
- Patients mentally or physically unable to comply with study requirements.
- Any serious medical condition or lab abnormalities posing unacceptable risk or confounding data.
- Pregnant or lactating females.
- Known intolerance or allergy to 5-ALA.
- Suspicious or documented acute or chronic porphyria.
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Trial Site Locations
Total: 2 locations
1
Tel Aviv sourasky medical center
Tel Aviv, Israel, Israel, 64239
Actively Recruiting
2
The Aviv Sourasky Medical Center
Tel Aviv, Israel, Israel, 64239
Actively Recruiting
Research Team
J
Jacob Bickels, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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