Clinical trial · Interventional
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
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After | — | UNRESOLVED | — |
| Surgical Resection | — | UNRESOLVED | — |
| The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-AminoLevulinicc Acid
- description
- 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.
- interventionNames
- Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
Primary outcomes (1)
- measure
- 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
- timeFrame
- three years
Secondary outcomes (1)
- measure
- To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 bilirubin \> 2X upper limit of normal. 2. Serum creatinine \> 2.5 x upper limit of normal. 3. Suspected /documented metastatic disease. 4. Active or uncontrolled infections. 5. Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study. 6. Use of other investigational agents \< 30 days prior to the study. 7. Patients who are mentally or physically unable to comply with all aspects of the study. 8. 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. 9. Pregnant or lactating females. 10. Known intolerance or allergy to 5-ALA 11. Suspicious or documented acute or chronic porphyria
References
Publications (0)
Data not yet available