NCT02672033 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2020-07-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Disease Specific Survival (DSS)

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outcome · POSTED

Local Control (LC)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Pathologic Complete Response Rate (pCR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Radiation: Hypofractionated Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery
label
Treatment (hypofractionated IMRT, pleurectomy/decortication)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (hypofractionated IMRT, pleurectomy/decortication)
description
Undergo accelerated hypofractionated IMRT
name
Hypofractionated Radiation Therapy
other Names
Hypofractionated Radiotherapy
hypofractionation
type
RADIATION
arm Group Labels
Treatment (hypofractionated IMRT, pleurectomy/decortication)
description
Undergo accelerated hypofractionated IMRT
name
Intensity-Modulated Radiation Therapy
other Names
IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy
type
RADIATION
arm Group Labels
Treatment (hypofractionated IMRT, pleurectomy/decortication)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (hypofractionated IMRT, pleurectomy/decortication)
description
Undergo pleurectomy/decortication
name
Therapeutic Conventional Surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
No data displayed because Outcome Measure has zero total participants analyzed.
measure
Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner
time Frame
Up to 1 year
description
No data displayed because Outcome Measure has zero total participants analyzed.
measure
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
description
No data displayed because Outcome Measure has zero total participants analyzed.
measure
Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
time Frame
Up to 5 years post-treatment

secondary Outcomes

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

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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offset unit
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query cond
Malignant Mesothelioma
query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice