Pleural Epithelioid MesotheliomaNCT02672033

Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma

A study testing Hypofractionated Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Pleural Epithelioid Mesothelioma and Pleural Malignant Mesothelioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
What is being tested?: Hypofractionated Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2015to 17 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed epithelioid predominantly (> 70%) subtype malignant pleural mesothelioma
Patient must have been evaluated by a University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure
Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study

Who cannot join

Patients who have previously received therapeutic radiation therapy to the chest
Active systemic, pulmonary, or pericardial infection
Use of chemotherapy within 4 weeks of the planned start of radiation therapy
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
Refusal to sign the informed consent
Patients who are participating in a concurrent treatment protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study

This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the feasibility and toxicity (both acute and chronic) of accelerated hypofractionated neoadjuvant helical intensity modulated radiation therapy prior to pleurectomy/decortication for malignant pleural mesothelioma.

SECONDARY OBJECTIVES:

To determine the pathologic complete response rate (pCR). II. To determine the tumor local control rate (LC). III. To determine the malignant pleural mesothelioma disease specific survival (DSS).

IV. To determine the overall survival (OS). V. To assess transforming growth factor beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury.

VI. To assess the changes in the postoperative pleural immunological milieu in terms of chemo- and cytokine expression.

OUTLINE:

Patients undergo 5 fractions of accelerated hypofractionated intensity-modulated radiation therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.

After completion of study treatment, patients are followed up at 6 weeks, and then every 3 months for 5 years.

Conditions: Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Being tested: Hypofractionated Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
Medical subject headings: Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, hypofractionation
Undergo accelerated hypofractionated IMRT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo accelerated hypofractionated IMRT
Laboratory Biomarker AnalysisOther
Correlative studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo pleurectomy/decortication

Study groups in NCT02672033
Study group	Role	What they receive
Treatment (hypofractionated IMRT, pleurectomy/decortication)	Experimental	Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT. Receives: Radiation: Hypofractionated Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 1 year
Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 3 months
Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 5 years post-treatment

Secondary outcomes (4)

Disease Specific Survival (DSS)
Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 5 years post-treatment
Local Control (LC)
Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 5 years post-treatment
Overall Survival (OS)
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 5 years post-treatment
Pathologic Complete Response Rate (pCR)
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 5 years post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201517 Jul 2018

First posted3 Feb 2016 (estimated)
Study start1 Sep 2015
Primary completion24 May 2016
Study completion17 Jul 2018

Why it stopped: slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pleural Epithelioid MesotheliomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02672033
Sponsor's protocol ID: 15-000487
Other IDs: NCI-2015-01736, JCCCID552, 15-000487
Status last verified: May 2019
First submitted: 2 Nov 2015
Last updated: 24 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Active, not recruitingPhase 1
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Biphasic Mesothelioma, Epithelioid Mesothelioma
Not yet recruitingPhase 3
A Phase 3 Trial in Advanced Epithelioid Mesothelioma
Pleural Mesothelioma, Mesothelioma
RecruitingPhase 1/2
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma
Active, not recruitingPhase 2
Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)
Pleural Mesothelioma

All Pleural Epithelioid Mesothelioma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study
ClinicalTrials.gov ID: NCT02672033
Acronym / sponsor ID: 15-000487
Conditions: Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow enrollment
Enrolment: 2 participants (actual)
Lead sponsor: Jonsson Comprehensive Cancer CenterUniversity, hospital or other
Study start: 1 Sep 2015 (actual)
Primary completion: 24 May 2016 (actual)
Study completion: 17 Jul 2018 (actual)
First posted: 3 Feb 2016 (estimated)
Results: Posted 18 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the feasibility and toxicity (both acute and chronic) of accelerated hypofractionated neoadjuvant helical intensity modulated radiation therapy prior to pleurectomy/decortication for malignant pleural mesothelioma.

SECONDARY OBJECTIVES:

To determine the pathologic complete response rate (pCR). II. To determine the tumor local control rate (LC). III. To determine the malignant pleural mesothelioma disease specific survival (DSS).

IV. To determine the overall survival (OS). V. To assess transforming growth factor beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury.

VI. To assess the changes in the postoperative pleural immunological milieu in terms of chemo- and cytokine expression.

OUTLINE:

After completion of study treatment, patients are followed up at 6 weeks, and then every 3 months for 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (hypofractionated IMRT, pleurectomy/decortication)	Experimental	Radiation: Hypofractionated Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional SurgeryPatients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologically confirmed epithelioid predominantly (> 70%) subtype malignant pleural mesothelioma
Patient must have been evaluated by a University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure
Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study

Key exclusion criteria (6 listed)

Patients who have previously received therapeutic radiation therapy to the chest
Active systemic, pulmonary, or pericardial infection
Use of chemotherapy within 4 weeks of the planned start of radiation therapy
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
Refusal to sign the informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypofractionated Radiation TherapyAlso: Hypofractionated Radiotherapy, hypofractionationUndergo accelerated hypofractionated IMRT	Radiation	Treatment (hypofractionated IMRT, pleurectomy/decortication)
Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated RadiotherapyUndergo accelerated hypofractionated IMRT	Radiation	Treatment (hypofractionated IMRT, pleurectomy/decortication)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (hypofractionated IMRT, pleurectomy/decortication)
Therapeutic Conventional SurgeryUndergo pleurectomy/decortication	Procedure or surgery	Treatment (hypofractionated IMRT, pleurectomy/decortication)

Primary outcome

Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner
Time frame: Up to 1 year
No data displayed because Outcome Measure has zero total participants analyzed.
Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 3 months
No data displayed because Outcome Measure has zero total participants analyzed.
Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
Time frame: Up to 5 years post-treatment
No data displayed because Outcome Measure has zero total participants analyzed.

4 secondary outcomes

Disease Specific Survival (DSS)
Time frame: Up to 5 years post-treatment
Local Control (LC)
Time frame: Up to 5 years post-treatment
Overall Survival (OS)
Time frame: Up to 5 years post-treatment
Pathologic Complete Response Rate (pCR)
Time frame: Up to 5 years post-treatment

Results and safety

Results posted to the registry on 18 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)	2	2

Primary outcome: Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner

Time frame: Up to 1 year

Population analysed: Data was not collected

Primary outcome: Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Time frame: Up to 3 months

Population analysed: Data was not collected

Primary outcome: Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0

Time frame: Up to 5 years post-treatment

Population analysed: Data was not collected

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from 10/2015 until 4/2018, 30 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)	2 of 2 (100%)	2 of 2 (100%)	2 of 2

Limitations and caveats (from the sponsor): Due to the rarity of malignant pleural mesothelioma only two patients were enrolled and treated. There number as insufficient for any analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pleural Epithelioid Mesothelioma

Active, not recruitingPhase 1/2
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Active, not recruitingPhase 1
Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Biphasic Mesothelioma, Epithelioid Mesothelioma
Not yet recruitingPhase 3
A Phase 3 Trial in Advanced Epithelioid Mesothelioma
Pleural Mesothelioma, Mesothelioma
RecruitingPhase 1/2
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma
Active, not recruitingPhase 2
Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)
Pleural Mesothelioma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Percy Lee principal investigator

UCLA / Jonsson Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.