Clinical trial NCT02672033: 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
Overall status: TERMINATED
Phase: NA
Conditions: Pleural Epithelioid Mesothelioma
Pleural Malignant Mesothelioma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner
timeFrame: Up to 1 year
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
timeFrame: Up to 3 months
measure: Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0
timeFrame: Up to 5 years post-treatment
Secondary outcomes:
measure: Disease Specific Survival (DSS)
timeFrame: Up to 5 years post-treatment
measure: Local Control (LC)
timeFrame: Up to 5 years post-treatment
measure: Overall Survival (OS)
timeFrame: Up to 5 years post-treatment
measure: Pathologic Complete Response Rate (pCR)
timeFrame: Up to 5 years post-treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Percy Lee
role: PRINCIPAL_INVESTIGATOR
References: