For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov. You can also send for our user-friendly Mesothelioma Clinical Trial Digest.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
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
Listing on www.clinicaltrials.gov
Sponsor- Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Location- UCLA Jonsson Comprehensive Cancer Center, Los Angeles California
Principal Investigator- Percy Lee M.D.
Contact-Percy Lee, M.D. 310 825 9775 PercyLee@mednet.ucka.edu
Number of Participants- 10
Purpose- “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 lining 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.”
Screening- Must be eligible for surgery- all lab tests and scans pre-op- which include- blood tests, X-rays, scans, EKG.
Eligibility Criteria- Histologically confirmed epithelioid predominantly (>70%) subtype malignant pleural mesothelioma
Patients must have been evaluated at the 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 women of child bearing potential, a negative urine or a 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 after the study.
Exclusions- 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 child bearing 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
How the research study is designed to work-“Patients undergo 5 sessions 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 treatments, patients are followed up to 6 weeks, and then every 3months for 5 years.”
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way progress to a cure for mesothelioma can be made is through clinical trials.
If you have any questions, let us know.