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

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
  60 mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia. 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 case of positive margins a second operation and 5-ALA administration or irradiation will be given.

Первичные конечные точки

• 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 [Срок оценки: three years]

Вторичные конечные точки (1)

• To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate. [Срок оценки: five years]

Критерии участия

Критерии включения

• 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. -

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 2 центра

• Tel Aviv sourasky medical center — Tel Aviv
• The Aviv Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT01898416 · TASMC-11-JB-558-CTIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗