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
Recruiting now · Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT01898416
- Run by
- michal roll
- People needed
- 140
- Starts
- 2013-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2013-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Tel Aviv sourasky medical center — Tel Aviv, Israel, Israel (enrolling)
- The Aviv Sourasky Medical Center — Tel Aviv, Israel, Israel (enrolling)
Full record on ClinicalTrials.gov
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