Study Stopped
slow enrollment
Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study
3 other identifiers
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2018
CompletedResults Posted
Study results publicly available
February 18, 2020
CompletedJuly 24, 2020
May 1, 2019
9 months
November 2, 2015
February 5, 2020
July 22, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Up to 5 years post-treatment
Secondary Outcomes (4)
Disease Specific Survival (DSS)
Up to 5 years post-treatment
Local Control (LC)
Up to 5 years post-treatment
Overall Survival (OS)
Up to 5 years post-treatment
Pathologic Complete Response Rate (pCR)
Up to 5 years post-treatment
Study Arms (1)
Treatment (hypofractionated IMRT, pleurectomy/decortication)
EXPERIMENTALPatients 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.
Interventions
Undergo accelerated hypofractionated IMRT
Undergo accelerated hypofractionated IMRT
Correlative studies
Undergo pleurectomy/decortication
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the rarity of malignant pleural mesothelioma only two patients were enrolled and treated. There number as insufficient for any analysis.
Results Point of Contact
- Title
- Dr. Percy Lee
- Organization
- Jonsson Comprehensieve Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Percy Lee
UCLA / Jonsson Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
February 3, 2016
Study Start
September 1, 2015
Primary Completion
May 24, 2016
Study Completion
July 17, 2018
Last Updated
July 24, 2020
Results First Posted
February 18, 2020
Record last verified: 2019-05