Clinical trial NCT01898416: 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
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-07-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 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

Primary outcomes:
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:
measure: To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
timeFrame: five years
Other outcomes:
Locations:
city: Tel AVIV
country: Israel
facility: Tel Aviv sourasky medical center
city: Tel Aviv
country: Israel
facility: The Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jacob Bickels, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: