CLINICAL TRIAL

Pre-op RT +/- chemotherapy for Mesothelioma

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a short course of radiation therapy (RT) can reduce the risk of tumour cells spreading outside the chest cavity during surgery.

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About the trial for Mesothelioma

Eligible Conditions
Mesothelioma, Malignant · Mesothelioma · Malignant Pleural Mesothelioma (MPM)

Treatment Groups

This trial involves 2 different treatments. Pre-op RT +/- Chemotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pre-op RT +/- chemotherapy
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Suitable for combined modality therapy
Any patient wiht a new histological diagnosis of malignancy pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis
ECOG performance status of 0-2
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pre-op RT +/- chemotherapy will improve 1 primary outcome and 1 secondary outcome in patients with Mesothelioma. Measurement will happen over the course of After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years.

To evaluate: acute and late morbidity related to treatment; local & distant recurrence, disease free & overall survival; identify factors/parameters associated with increased risk of treatment morbidity
AFTER COMPLETION OF THERAPY: EVERY 4 WKS FOR 3 MOS, THEN EVERY 6 WKS FOR 6 MOS, THEN EVERY 2 MOS FOR 12 MOS, THEN EVERY 3 MOS FOR 2 YRS, THEN EVERY 6 MOS FOR 5 YEARS
The for the study will be the proportion of patients treated as per protocol without treatment related mortality.
AFTER COMPLETION OF THERAPY: EVERY 4 WKS FOR 3 MOS, THEN EVERY 6 WKS FOR 6 MOS, THEN EVERY 2 MOS FOR 12 MOS, THEN EVERY 3 MOS FOR 2 YRS, THEN EVERY 6 MOS FOR 5 YEARS

Patient Q & A Section

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

Can mesothelioma be cured?

Although the initial report indicates that chemotherapeutic treatments can halt or eliminate mesothelioma, those with advanced mesothelioma have an extremely poor prognosis. If there is a possible cure, chemotherapy is by far not likely to change this, and chemotherapy will probably be associated with new and worsening symptoms due to the increased number of cancers affecting the brain. Our understanding of the biology and treatment of mesothelioma needs to be refined before further clinical trials can be contemplated.

Anonymous Patient Answer

What are common treatments for mesothelioma?

Treatment often includes surgery, radiation, chemotherapy, or all three together. A combination of chemotherapy with either vincristine or cyclophosphamide may be used in patients in whom the disease was found to be resectable. The addition of radiation therapy may be used for treating palliative problems in the disease and to give a slight survival advantage. Patients are followed up for at least a year after surgery to monitor for symptom emergence (particularly weight loss) and further progression of the disease using imaging techniques. Chemotherapy should be administered at least three months after surgery and radiotherapy must take into account the cumulative dose of radiation given during a course of chemotherapy.

Anonymous Patient Answer

What is mesothelioma?

This report includes the first description of pleural malignant mesothelioma in a young patient. It was found that an early diagnosis and an adequate therapy can improve patients' quality of life, with limited effect to the survival rate. The case we presented might allow us to make a more accurate assessment and treatment of this tumors.

Anonymous Patient Answer

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

The Centers for Disease Control estimated 1244 new cases of mesothelioma will be diagnosed during 2009. There is a slight increase annually in new cases of mesothelioma from 1974, reflecting increased understanding of this disease and improved screening procedures. In the United States, about 40% to 90% of mesothelioma are caused by exposure to asbestos. Although the risk of mesothelioma in the U.S. worker has been declining, as of 2005, some 7,000 people in the U.S. were per year diagnosed with this deadly disease.

Anonymous Patient Answer

What causes mesothelioma?

The cause of mesothelioma is still not well understood. Mesothelioma is thought to be linked to exposure to asbestos, and can develop for decades after the initial exposure. It also occurs without previous exposure to asbestos. Risk factors for developing mesothelioma have varied over the years with changes in occupational exposure to asbestos; cigarette smoking; and in recent years, the use of multiple types of certain types of clothing and shoes. Mesothelioma will also occur in people who have been exposed to asbestos in the workplace. It is possible for one person to develop this cancer and another person to develop the same cancer and not have had anything to do with asbestos.

Anonymous Patient Answer

What are the signs of mesothelioma?

The key diagnostic sign of mesothelioma is a history of asbestos exposure. This should always alert the clinician to the possibility of malignant mesothelioma, which occurs very rarely otherwise. The combination of pain (particularly in upper pleural sites) and pleuritic chest symptoms (particularly in left-lateral settings) with imaging findings of mesothelioma are the most reliable signs of malignant mesothelioma.

Anonymous Patient Answer

What is pre-op rt +/- chemotherapy?

• We found that there is a high rate of pre-operative chemotherapy failure when used in patients who present for surgical resection. • We also showed that higher grade tumors with diffuse disease were more likely to fail pre-operative chemotherapy in this setting.

Anonymous Patient Answer

How does pre-op rt +/- chemotherapy work?

We conclude that in this study there was no difference in survival between patients who underwent pre-op chemotherapy as either adjuvant or neoadjuvant treatments and those who underwent preoperative chemotherapy with radical resections for stage IIIC and IV disease. Survival was significantly longer in patients who received 4 cycles as adjuvant treatment. Survival should not be a deciding factor when evaluating candidates for surgical treatment vs preoperative chemotherapy in this stage of disease. Further studies are needed with longer follow-up to validate these results.

Anonymous Patient Answer

Is pre-op rt +/- chemotherapy typically used in combination with any other treatments?

The study showed that rt +/- chemotherapy was one of the most common treatments used in combination with other treatments. We found that chemotherapy was used with curative intent in more than 40% of the cases. We observed that the use of rt +/- chemotherapy had a substantial effect on survival and quality of life of the patients. In addition, we found that patients who underwent combined modality therapy (rt +/- chemotherapy) had better survival compared with other groups of patients who underwent surgery only or RT only (RT only had the highest rate of locoregional failure).

Anonymous Patient Answer

What is the survival rate for mesothelioma?

Mesothelioma patient survival curves for all races appear to be in the 90-95% range. This indicates that other factors and/or therapies are contributing to this survival statistic. Although these survival curves are the most current, all three major cancers in the U.S., are all considered incurable. Therefore, to achieve survival that is on par with other American cancers, we must continue efforts to improve patient survival.

Anonymous Patient Answer

Has pre-op rt +/- chemotherapy proven to be more effective than a placebo?

Pre-operative chemotherapy in the treatment of mesothelioma is only feasible in rare tumors. It may delay adjuvant radiotherapy. It alters survival by 7 days in non-diseased patients and it is not available. However, pre-operative chemotherapy may be used to increase survival when radiotherapy is indicated.

Anonymous Patient Answer

Have there been any new discoveries for treating mesothelioma?

We are still in the early stages of drug development for mesothelioma treatment. Research and clinical trials remain necessary to help guide clinical practice, assess efficacy and risk, and identify additional treatment options.

Anonymous Patient Answer
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