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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 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

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 more
Other 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 • 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%
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
231 Previous Clinical Trials
100,808 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,259 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
396 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04158141 — Phase 3
Pleural Malignant Mesothelioma Research Study Groups: Arm I (Step 1: chemotherapy, P/D: Step 2: no treatment), Arm II (Step 1: chemotherapy, P/D, Step 2: IMRT/PBS)
Pleural Malignant Mesothelioma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04158141 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04158141 — Phase 3

Frequently Asked Questions

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

What does the FDA have to say about Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy is considered safe, as it has received a score of 3."

Answered by AI

How do I sign up for this clinical trial?

"This study is looking for 150 patients with mesothelioma that are malignant and between the ages of 18-80. Candidates must meet the following registration criteria: have a physical examination and history less than 42 days old, an FEV1 score of 40% or higher, imaging proof of clinical stage by PET/CT scan also less than 42 days old."

Answered by AI

What are the primary conditions that people usually seek Intensity-Modulated Radiation Therapy treatment for?

"According to the National Cancer Institute, Intensity-Modulated Radiation Therapy can be used as an initial treatment for advanced thymoma and testicular cancer."

Answered by AI

Are there any current vacancies in this research project for participants?

"Correct, this clinical trial is still recruiting participants. The original posting went up on January 29th 2020 with the most recent edit taking place on September 15th of this year."

Answered by AI

Does this particular research project test subjects who are elderly?

"Eligibility criteria for this study includes being between 18-80 years old."

Answered by AI

Where are patients being treated with this experimental therapy?

"There are 13 sites enrolling patients for this trial, which are located in Rochester, Chicago, Boston and 10 other locations. If you wish to participate in this trial, it is ideal to select the clinic closest to your location to minimize travel requirements."

Answered by AI

How many patients are included in this research project?

"Yes, that is correct. The clinical trial in question was originally posted on 1/29/2020 and updated as recently as 9/15/2022 according to the information available on clinicaltrials.gov. This particular trial is looking for 150 patients at 13 locations."

Answered by AI

What is the general efficacy of Intensity-Modulated Radiation Therapy in cancer patients?

"City of Hope Comprehensive Cancer Center first studied Intensity-Modulated Radiation Therapy in 1997 and, since then, there have been 2042 completed clinical trials. As it stands, 1258 live studies are taking place with many of them based in Rochester, Minnesota."

Answered by AI
~3 spots leftby Mar 2025