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
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- michal roll · Government
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient has a resectable histologically confirmed desmoid tumor.
2. Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
3. Age \> 18 years
4. Signed informed consent prior to patient recruitment. -
Exclusion Criteria:
1. Hepatic enzymes or bi…
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