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Alkylating agents
Targeted Radiation Therapy + Surgery + Chemotherapy for Malignant Pleural Mesothelioma
Phase 3
Waitlist Available
Led By Andreas Rimner, MD
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether adding targeted radiation therapy to surgery and chemotherapy will work better to treat stage I-IIIA malignant pleural mesothelioma.
Eligible Conditions
- Pleural Malignant Mesothelioma
- Pleural Mesothelioma
- Mesothelioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Neoplasm Metastasis
Incidence of treatment-related toxicity
Local-failure-free survival (LFFS)
+2 moreOther outcome measures
Association between radiation dose to gross residual disease and local control
Degree of under-staging, concordant and upstaging between centrally-reviewed clinical staging and pathologic staging
Rate of R0/R1 and R2 resections, by type of procedures (extended pleurectomy/decortication (P/D), P/D and partial pleurectomy)
Side effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Wound dehiscence
10%
Vascular access complication
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)Experimental Treatment10 Interventions
STEP 1: Patients undergo P/D then within 4 to 8 weeks receive pemetrexed IV over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1. Patients may instead receive pemetrexed IV over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1 then undergo P/D within 4 to 8 weeks after chemotherapy. The order of surgery and chemotherapy is at the discretion of the treating physician.
STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions IMRT or PBS proton therapy 5 days per week over 6 weeks.
Group II: Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment)Experimental Treatment8 Interventions
STEP 1: Patients undergo P/D then within 4 to 8 weeks receive pemetrexed IV over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1. Patients may instead receive pemetrexed IV over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1 then undergo P/D within 4 to 8 weeks after chemotherapy. The order of surgery and chemotherapy is at the discretion of the treating physician.
STEP 2: Patients receive no treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed Disodium
2015
Completed Phase 2
~280
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Decortication
2015
N/A
~20
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,762 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,347 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
396 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a large amount of leftover disease in a specific part of your lung that makes it difficult to perform a certain type of radiation treatment called pleural IMRT.You need to use extra oxygen to help you breathe.You have had a surgical procedure called extrapleural pneumonectomy.You have fluid in the space between your lungs and chest wall that cannot be controlled by draining it, or your lung does not expand enough after a specific procedure.You have had a kidney removed on the opposite side of the study.You have received radiation treatment to your chest area in the past, and cannot receive additional radiation treatment in that area due to the risk of harming normal tissues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment)
- Group 2: Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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