Using 5-ALA to prevent tumor recurrence in desmoid tumor patients
Official title: 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.
Run by Tel-Aviv Sourasky Medical Center · NCT01898416 · Data updated 2026-11-12
This study is testing if taking a medication called 5-ALA before surgery and using red light therapy afterward can help prevent desmoid tumors from coming back in patients who have had surgery to remove them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Tel Aviv, Israel and 1 other locations) |
| Status | Recruiting |
| Started | June 2013 |
| Main results expected | December 2023 |
| Study ends | December 2026 |
| Registry record updated | October 31, 2013 |
| Trial ID | NCT01898416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with resectable, histologically confirmed desmoid tumors, including those previously treated.
✕Probably not a fit
Patients with metastatic disease, uncontrolled infections, or serious medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of oral 5-ALA administration followed by intraoperative phototherapy using red light laser as an adjuvant treatment for patients with desmoid tumors after surgical resection. The primary goal is to assess the rate of local tumor recurrence over three years. Additionally, the study aims to ensure the safety of 5-ALA administration in this patient population. Participants will be monitored for any adverse effects and overall clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of local tumor recurrence in patients with desmoid tumors.
How similar studies have gone: While the specific combination of 5-ALA and phototherapy is novel, similar approaches in photodynamic therapy have shown promise in other tumor types.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Tel Aviv sourasky medical center
Tel Aviv, Israel, Israel Recruiting -
The Aviv Sourasky Medical Center
Tel Aviv, Israel, Israel Recruiting
Study contacts
- Principal investigator: Jacob Bickels, MD/PhD — Tel-Aviv Sourasky Medical Center
- Study coordinator: Jacob Bickels, MD/PhD
- Email: jACOBB@TLVMC.GOV.IL
- Phone: +972-524266341
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.