Varying Doses of Background and Boost RT for Mesothelioma

Phase-Based Estimates
1
Effectiveness
1
Safety
Princess Margaret Hospital, University Health Network, Toronto, Canada
Mesothelioma+2 More
Varying Doses of Background and Boost RT - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Mesothelioma

Study Summary

This study is evaluating whether a boost radiation dose can be tolerated in patients with malignant pleural mesothelioma.

See full description

Eligible Conditions

  • Mesothelioma
  • Mesothelioma, Malignant
  • Mesothelioma; Lung

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Varying Doses of Background and Boost RT will improve 1 primary outcome and 4 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of Up to five years.

Up to five years
Evaluating patients' pain
Local recurrence
Maximum Tolerated Dose for Background Radiation
Patient Morbidity
Patients' quality of life

Trial Safety

Trial Design

2 Treatment Groups

Control
Radiation

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. Varying Doses Of Background And Boost RT 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.

Radiation
Radiation
This study involves a 3+3 design. The starting cohort (n=3) will receive a neoadjuvant Background dose to the affected hemithorax (starting at 0 cGy) as well as concomitant Boost dose (of at least 2100 cGy) to a part of the gross tumour volume (GTV). The radiation will be delivered over 3 alternate days over 5-7 calendar days followed by macroscopically complete extensive pleural resection (either extra-pleural pneumonectomy or extended pleurectomy decortication, at the surgeon's discretion) after 7 to 14 days. If no dose limiting toxicities (DLTs) seen, then the Background RT dose will be increased by 600 cGy (up to 1800 cGy) and the cohort (n=3) for the next dose level will be accrued. If only 1 DLT seen, then an additional 3 patients will be treated on this dose level. If 2 or more DLTs seen at any given dose level, then the previous dose level will be defined as the maximum tolerated dose (MTD). Patients will be stratified by type of resection.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

Princess Margaret Hospital, University Health Network - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Good pulmonary function precluding radiation therapy (FEV1>1 L or >40% predicted or DLCO >45% predicted)
Any patient with a new histological diagnosis of malignant pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis.
Suitable for combined modality therapy
Informed consent.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Stage T1-3 N0-1 M0 according to the 8th edition of the tumor, node, and metastases (TNM) staging system based on conventional investigations and tests (Appendix 1). Note that the updated TNM staging system now categorizes ipsilateral mediastinal nodes as N1 disease.

Patient Q&A Section

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

What causes mesothelioma?

Add answer

The cause of mesothelioma is known to be environmental. Chemical factors are also thought to be able to induce tumors that are genetically susceptible to develop. It is clear that there are a considerable number of mesotheliomas which were triggered by environmental factors. It is therefore logical that these cancers are difficult to treat as these factors might be able to cause recurrence and survival failure. Thus treatment of mesothelioma will need to incorporate biological modifiers that can prevent or slow down an existing cancer from spreading.

Unverified Answer

What are common treatments for mesothelioma?

Add answer

Common treatment for mesothelioma includes surgery, chemotherapy, and radiation therapy (chemotherapy and radiation therapy are often used as a palliative measure). Surgery and chemotherapy may involve the creation of a surgical or interventional pneumonectomy or a lung parenchyma transplant. There is no cure for mesothelioma, so treatment is focused on managing symptoms and maintaining quality of life. Mesothelioma occurs most frequently in people over 50 who are exposed to asbestos.

Unverified Answer

Can mesothelioma be cured?

Add answer

Because the median survival after diagnosis is only 2 months, and only one-quarter of metastatic mesothelioma patients are known to be curable with surgery, radiation therapy, chemotherapy, and/or surgery, there are important and potentially fruitful therapeutic possibilities for mesothelioma. The identification of therapeutic targets that are frequently aberrant in mesothelioma may enable a more effective and personalized approach to the management.

Unverified Answer

What are the signs of mesothelioma?

Add answer

Signs of mesothelioma including paraneoplastic neurological disorders and pain due to a tumor can be detected. In the absence of clinical symptoms, a workup including magnetic resonance imaging may reveal the presence of a large malignant tumor, even in the asymptomatic patients.

Unverified Answer

How many people get mesothelioma a year in the United States?

Add answer

Mesothelioma occurrence appears to be higher in areas with a high density of asbestos work sites. A number of geographic subtypes of mesothelioma can be identified. The distribution of age-adjusted rates is inversely related to age and to male sex. The highest occurrences are in Iowa, Mississippi, Maine, Massachusetts, Virginia, and Maryland. Mesothelioma occurs most frequently between the ages of 75 and 79 years and has a peak of occurrence from 80 to 89 years old. However, the age distribution of occurrences varies across the United States and around the world, with occurrences in Ireland being much lower than ones in the United States.

Unverified Answer

What is mesothelioma?

Add answer

The prevalence of malignant pleural mesothelioma (or MPM) has increased with decreasing occupational exposures to asbestos in the United States. This increase is likely because of the increased use of asbestos in home repairs, construction, and other industries.

Unverified Answer

What is the average age someone gets mesothelioma?

Add answer

An estimated 20% of the people with mesothelioma will be diagnosed before age 65, and 4% will be over 90 in the age group 70+. This indicates that mesothelioma could prove to be the primary cancer for an unusually long period of time. Mesothelioma often occurs later in men (average age of diagnosis of men is 74, whereas it is 67 for women).

Unverified Answer

Is varying doses of background and boost rt safe for people?

Add answer

In a recent study, findings of this study do not support the notion that the use of different doses of background irradiation and boost irradiation may be safe for patients receiving two-field WLP or IM-WLP breast irradiation. An exception is a small decrease in the incidence of Grade 2 myelotoxicosis with the use of 2.8 Gy background dose and 10 Gy boost dose in the WLP-IM combination.

Unverified Answer

Does mesothelioma run in families?

Add answer

Findings from a recent study of the present study indicate that no specific family factors are responsible, at least in most families, for the presence of mesothelioid tumors. It is highly advisable to prevent and treat all the exposed families with malignant tumors.

Unverified Answer

What is varying doses of background and boost rt?

Add answer

Background radiation (BR) is typically used for radiotherapy of all tumors in the treatment of cancer in order to kill cancer cells and reduce the tumor size. The boost radiation protocol is the radiation therapy with an additional dose of radiation tailored to each individual patient in order to improve the treatment outcome and prolong overall survival.

Unverified Answer

Has varying doses of background and boost rt proven to be more effective than a placebo?

Add answer

Patients benefited from either the background or boost regimen. The most significant statistical differences between groups were found at 12 weeks, when both treatment regimens were more effective than placebo.

Unverified Answer

What are the chances of developing mesothelioma?

Add answer

There are no real chances to develop it. That was proven when it was first mentioned and its symptoms became more well known. In fact, the first symptoms may be mistaken for other, less serious illnesses. It was said that it is diagnosed by the very small amount of cancer that seems to grow from the testicles or from the abdomen. It may be found when a person is already quite high-risk because of the age and other factors. These factors are genetic.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Mesothelioma by sharing your contact details with the study coordinator.