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

Primary Purpose

Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation Therapy
Intensity-Modulated Radiation Therapy
Laboratory Biomarker Analysis
Therapeutic Conventional Surgery
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Epithelioid Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (hypofractionated IMRT, pleurectomy/decortication)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
No data displayed because Outcome Measure has zero total participants analyzed.

Secondary Outcome Measures

Disease Specific Survival (DSS)
Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.
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.
Overall Survival (OS)
No data displayed because Outcome Measure has zero total participants analyzed.
Pathologic Complete Response Rate (pCR)
No data displayed because Outcome Measure has zero total participants analyzed.

Full Information

First Posted
November 2, 2015
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02672033
Brief Title
Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
Official Title
Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
July 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (hypofractionated IMRT, pleurectomy/decortication)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Other Intervention Name(s)
Hypofractionated Radiotherapy, hypofractionation
Intervention Description
Undergo accelerated hypofractionated IMRT
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Intervention Description
Undergo accelerated hypofractionated IMRT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo pleurectomy/decortication
Primary Outcome Measure Information:
Title
Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner
Description
No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 1 year
Title
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
Description
No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 3 months
Title
Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
Description
No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 5 years post-treatment
Secondary Outcome Measure Information:
Title
Disease Specific Survival (DSS)
Description
Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 5 years post-treatment
Title
Local Control (LC)
Description
Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 5 years post-treatment
Title
Overall Survival (OS)
Description
No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 5 years post-treatment
Title
Pathologic Complete Response Rate (pCR)
Description
No data displayed because Outcome Measure has zero total participants analyzed.
Time Frame
Up to 5 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Percy Lee
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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