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
- Stage IIIA Pleural Malignant Mesothelioma
- Stage II Pleural Malignant Mesothelioma
- Pleural Mesothelioma
- Pleural Biphasic Mesothelioma
- Stage IA Pleural Malignant Mesothelioma
- Stage IB Pleural Malignant Mesothelioma
- Stage I Pleural Malignant Mesothelioma
- Mesothelioma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Up to 5 years
Year 5
Progression-free survival (PFS)
Year 5
Neoplasm Metastasis
Year 5
Local-failure-free survival (LFFS)
Year 5
Overall survival (OS)
Up to 5 years
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
Incidence of treatment-related toxicity
Quality of Life (QOL)/patient-reported Outcome (PRO)
Rate of R0/R1 and R2 resections, by type of procedures (extended pleurectomy/decortication (P/D), P/D and partial pleurectomy)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Randomized Arm 2: TMZ+RT + Bevacizumab
80%Fatigue
61%Nausea
56%Alopecia
56%Platelet count decreased
55%Headache
47%Constipation
42%Anorexia
40%Hyperglycemia
39%Leukopenia
38%Lymphopenia
37%Hemoglobin decreased
31%Alanine aminotransferase increased
27%Neutrophil count decreased
27%Vomiting
25%Dizziness
25%Insomnia
24%Hyponatremia
24%Memory impairment
24%Aspartate aminotransferase increased
22%Hypertension
21%Diarrhea
20%Seizure
19%Muscle weakness
18%Depression
18%Weight loss
18%Hypocalcemia
18%Taste alteration
17%Joint pain
17%Cough
17%Hypoalbuminemia
16%Radiation recall reaction (dermatologic)
16%Peripheral sensory neuropathy
16%Vision blurred
15%Hypokalemia
15%Pain in extremity
15%Ataxia
14%Anxiety
14%Edema limbs
14%Dermatitis radiation
14%Confusion
14%Peripheral motor neuropathy
14%Rash desquamating
13%Laboratory test abnormal
12%Pruritus
12%Speech disorder
12%Creatinine increased
11%Hemorrhage nasal
11%Tremor
11%Dyspnea
11%Back pain
10%Myalgia
10%Mucositis oral
10%Alkaline phosphatase increased
9%Cognitive disturbance
9%Fever
9%Proteinuria
9%Dyspepsia
8%Chills
8%Dehydration
8%Muscle weakness lower limb
8%Urinary frequency
8%Voice alteration
8%Thrombosis
8%Hyperkalemia
8%Depressed level of consciousness
8%Neurological disorder NOS
7%Tinnitus
7%Hypoglycemia
7%Pain [other]
7%Dry skin
7%Allergic rhinitis
7%Abdominal pain
7%Hearing loss
7%Gait abnormal
7%CD4 lymphocytes decreased
7%Hyperbilirubinemia
6%Acne
6%Blood disorder
6%Agitation
6%Eye disorder
5%Dry mouth
5%Dysphagia
5%Localized edema [head and neck]
4%Skin disorder
3%Muscle weakness left-sided
3%Death
3%Musculoskeletal disorder
2%Opportunistic infection
2%Wound dehiscence
2%Colonic perforation
2%Hypermagnesemia
2%Ischemia cerebrovascular
1%Vascular access complication
1%Intracranial hemorrhage
1%Mental status changes
1%Pneumonitis
1%Erythema multiforme
1%Myocardial ischemia
1%Disease progression
1%Febrile neutropenia
1%Atrial fibrillation
1%Hypoxia
1%Weight gain
1%Chest pain
1%Hypersensitivity
1%Pneumonia [with unknown ANC]
1%Wound infection [with normal or Grade 1-2 ANC]
1%Encephalopathy
1%Respiratory disorder
Trial Design
2 Treatment Groups
Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment)
1 of 2
Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)
1 of 2
Experimental Treatment
150 Total Participants · 2 Treatment Groups
Primary Treatment: Intensity-Modulated Radiation Therapy · No Placebo Group · Phase 3
Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment)Experimental Group · 8 Interventions: Questionnaire Administration, Pemetrexed Disodium, Carboplatin, Cisplatin, Pemetrexed, Pleurectomy, Quality-of-Life Assessment, Decortication · Intervention Types: Other, Drug, Drug, Drug, Drug, Procedure, Other, Procedure
Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)Experimental Group · 10 Interventions: Questionnaire Administration, Pemetrexed Disodium, Carboplatin, Cisplatin, Pemetrexed, Pencil Beam Scanning, Pleurectomy, Quality-of-Life Assessment, Intensity-Modulated Radiation Therapy, Decortication · Intervention Types: Other, Drug, Drug, Drug, Drug, Radiation, Procedure, Other, Radiation, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Carboplatin
FDA approved
Cisplatin
FDA approved
Pemetrexed
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660
Decortication
2015
N/A
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
NRG OncologyLead Sponsor
219 Previous Clinical Trials
95,374 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,321 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
388 Total Patients Enrolled
Eligibility Criteria
Age 18 - 80 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a FEV1 of less than 40% of the predicted value.
You have a minimum of 3000 white blood cells per cubic millimeter of blood within 30 days prior to Step 1 Registration.
Imaging proof of clinical stage (AJCC 8th edition) I-IIIA MPM by PET/CT within 42 days prior to registration.
You have a Karnofsky performance status of 80 or higher within 42 days prior to registration.
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Conditions
Cancer Related
Treatments