Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) for Malignant Neoplasm of Pancreas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Canada
Malignant Neoplasm of Pancreas+5 More
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new type of radiation therapy can be used to treat pancreatic cancer.

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Eligible Conditions

  • Malignant Neoplasm of Pancreas
  • Unresectable Pancreatic Cancer
  • Adenocarcinomas of the Pancreas
  • Pancreatic Metastatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasm of Pancreas

Study Objectives

This trial is evaluating whether Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) will improve 2 primary outcomes and 6 secondary outcomes in patients with Malignant Neoplasm of Pancreas. Measurement will happen over the course of Day 0 (Day of insertion).

Year 2
Efficiency - Long-term effect
3 to 24 months
Safety - Adverse events
Week 6
Efficiency - Short-term effect
Day 60
Change in quality of life: EORTC-QLQ-C30
Change in quality of life: QLQ-PAN26
Tissue damage evaluation
Day 0
Feasibility - DaRT seed placement
Month 24
Stent durability

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasm of Pancreas

Trial Design

1 Treatment Group

DaRT Seeds
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

DaRT Seeds
Device
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
2017
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years following dart seeds insertion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years following dart seeds insertion for reporting.

Closest Location

Centre Hospitalier de l'Université de Montréal (CHUM) - Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
ECOG performance status ≤ 2
Measurable lesion per RECIST (version 1.1) criteria
Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
≥ 18 years of age
Estimated life expectancy of at least 12 weeks
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
Subjects are willing to sign an informed consent

Patient Q&A Section

What causes cancer of pancreas?

"As an incurable disease, a constant change in the pancreas is observed. The pancreatic tissues show a steady change from duct cells, acinar cells to islet cells, each type of cell presents individually in different organs in a different location. Thus, the pancreas seems to be perpetually growing and dividing to generate new components of the pancreas, and also changing into other forms. The endocrine imbalance hypothesis is supported by the facts that acute/chronic pancreatitis is the most common cause of acute pancreatic disease. Also, the change of normal pancreas may have a leading role in pancreatic cancer. What is known about this subject can all be found in this article." - Anonymous Online Contributor

Unverified Answer

What is cancer of pancreas?

"Pancreatic cancer is a malignant disease that most commonly affects middle-aged men and women. It forms in the glandular tissues of the pancreas and is usually detected at an advanced stage. It is associated with high mortality rates. It is the fourth leading cause of cancer deaths in Japan. Pancreatic cancer has a poor prognosis with an average 5-year survival rate below 10%. Patients need to be carefully monitored for recurrence and signs of recurrence." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer of pancreas?

"Symptoms of cancer of pancreas are similar to the general signs and symptoms of pancreatic cancer and are similar to the common signs reported by primary health-care practitioners." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer of pancreas?

"Treatment for an ACC, NSCLC, or other malignancy is similar to treatment of malignancies more common elsewhere in the body. Surgical resection of the tumor and lymph node dissection, with or without adjuvant chemotherapy, should be considered to preserve the remaining pancreas if feasible. Advanced or unresectable disease dictates the use of chemotherapy and biological agents such as bevacizumab and PD-1 inhibitors." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of pancreas a year in the United States?

"The number of pancreatic cancers diagnosed in the U.S. population will steadily increase, with an expected increase of 8 in 10 men and 4 in10 women from 2000 to 2030. The age-adjusted rate has not change significantly in the last 65 years." - Anonymous Online Contributor

Unverified Answer

Can cancer of pancreas be cured?

"Surgery can be considered as an option to cure tumors where a cure is not possible but the patient will be better-off with a surgery than with no treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer of pancreas?

"Alcohol, smoking, diet, diabetes, and obesity are not the main causes of pancreas cancer. The question is: is tobacco carcinogenesis modified by low sodium diet? answer: Data from a recent study show that low sodium diet is associated with a significant decrease in the risk of pancreatic cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in radiation: diffusing alpha radiation emitters therapy (dart) for therapeutic use?

"In the United States, only 1-in-15 patients with pancreatic cancer are thought to receive the treatment currently available. Although this radiotherapy is effective, further improvements are needed." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer of pancreas?

"[Cancers of the pancreas are difficult to diagnose clinically and are usually diagnosed post-mortem as an resectable tumour after pancreatectomy] Given the challenges in diagnosis, this field is still very limited. Recent breakthroughs involve the use of antibodies against tumour antigens in combination with immunotherapy to tackle tumour cells and their infiltrating inflammatory cells. These antibodies represent possible therapeutic targets to complement resection surgery." - Anonymous Online Contributor

Unverified Answer

Has radiation: diffusing alpha radiation emitters therapy (dart) proven to be more effective than a placebo?

"Data from a recent study shows that dART is more effective in reducing the volume of tumor and improving the local control rate and survival rate of patients with advanced tumors undergoing pancreatic cancer and a single dART dose is safe with a small chance of severe adverse effects." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer of pancreas?

"For our group of patients, a clinical trial was not considered. It seemed to be more of a chance to get benefit from a new treatment as there was an opportunity of getting cure. The chance of cure in patients with a low (0,1%) risk of relapse are very low and no patient would miss out on a trial, so the clinical trial offer seems not worthwhile in these circumstances." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving radiation: diffusing alpha radiation emitters therapy (dart)?

"Use of Alpha particle emitters, including radon (dart) in the treatment of pancreatic carcinoma is a widely used therapy, but the rationale for the use of alpha emitter sources for the treatment of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) needs to be re-examined based on the new information concerning adverse effects of radiation on the hematopoietic system and the possible carcinogenic effects of alpha emitter therapies. These newer data raise new possibilities for the use of radiation therapies in the future management of patients with these metastatic cancers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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