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Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma

NCT04158141 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-19

Study results available
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Summary

This trial studies how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery and chemotherapy may work better than surgery and chemotherapy alone for the treatment of malignant pleural mesothelioma.

Conditions

  • Pleural Biphasic Mesothelioma
  • Pleural Epithelioid Mesothelioma
  • Stage I Pleural Malignant Mesothelioma AJCC v8
  • Stage IA Pleural Malignant Mesothelioma AJCC v8
  • Stage IB Pleural Malignant Mesothelioma AJCC v8
  • Stage II Pleural Malignant Mesothelioma AJCC v8
  • Stage IIIA Pleural Malignant Mesothelioma AJCC v8

Interventions

DRUG

Carboplatin

Intravenously

DRUG

Cisplatin

Intravenously

PROCEDURE

Decortication

Undergo decortication

RADIATION

Intensity-Modulated Radiation Therapy

Daily fractions

DRUG

Pemetrexed

Intravenously

DRUG

Pemetrexed Disodium

Intravenously

RADIATION

Pencil beam scanning proton therapy

Daily fractions

PROCEDURE

Pleurectomy

Undergo pleurectomy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Andreas Rimner, MD · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2023-11-20
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158141 on ClinicalTrials.gov