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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

Pivotal Trial

No Placebo-Only Group

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

Mesothelioma
Pleural Malignant Mesothelioma
Pleural 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

Neoplasm Metastasis

Incidence of treatment-related toxicity

Local-failure-free survival (LFFS)

+2 more

Other study objectives

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 • NCT00884741

30%

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%

Vascular access complication

10%

Wound dehiscence

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%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

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.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Pemetrexed Disodium

2015

Completed Phase 2