The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as anPhase 2NCT01898416
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 study testing 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. in people with The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an and Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After, run by michal roll at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2013to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Tel Aviv sourasky medical center
Tel Aviv, Israel, 64239
Jacob Bickels, MD/PhD, +972-524266341, JACOBB@TLVMC.GOV.IL
- Recruiting
The Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Jacob Bickels, MD/PhD, +972-524266341, jacobb@tlvmc.gov.il
Jacob Bickels, MD/PhD
About this study
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.
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
- 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
- Being tested
- 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-AminoLevulinicc Acid | Experimental | 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. Receives: Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three years
Secondary outcomes (1)
To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
Data from all subjects who receive any study drug will be included in the safety analyses. The severity of the toxicities will be graded according to the NCI CTCAE whenever possible. Adverse events will be summarized by worst NCI CTC grade. Adverse events classified as NCI CTCAE Grade 3 or Grade 4, study-drug-related events, and serious adverse events will be summarized separately. Laboratory data will be graded according to NCI CTCAE severity grade.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as anStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- michal roll
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Jacob Bickels, MD/PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898416
- Sponsor's protocol ID
- TASMC-11-JB-558-CTIL
- Status last verified
- Oct 2013
- First submitted
- 26 Jun 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01898416
- Acronym / sponsor ID
- TASMC-11-JB-558-CTIL
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- michal rollOther government
- Study start
- Jun 2013
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-AminoLevulinicc Acid | Experimental | Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 5-AminoLevulinicc Acid |
Primary outcome
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
Time frame: three years
1 secondary outcome
To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
Time frame: five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Bickels, MD/PhD principal investigator
Tel-Aviv Sourasky Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. in people with The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an and Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After, run by michal roll at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Bickels, MD/PhD (+972-524266341, jACOBB@TLVMC.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.