The Role of Adaptive Radiation Planning in Patients with Non-Small Cell Lung Cancer on Radiation Induced Toxicity .
To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue.
Chemotherapy (NOS)
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
- Written informed consent and Health Insurance Portability and Accountability Act
(HIPAA) authorization for release of personal health information
- Histologically or cytological evidence of locally advanced, biopsy-proven, stage II
(inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with
chemoradiation with concurrent or adjuvant immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow laboratory values for radiation therapy deemed by
appropriate the investigator obtained within 14 days prior to registration for
protocol therapy
- Women of childbearing potential (WOCBP) must obtain a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic
gonadotropin [HCG]) at day -30 to day 0
- Women of childbearing potential must be willing to abstain from heterosexual activity
or use an effective method of contraception during the time of the study period
- Men who are sexually active with WOCBP must use any contraceptive method with a
failure rate of less than 1% per year
Exclusion Criteria
- History or current evidence of any condition, therapy, or laboratory abnormality that
might confound the results of the trial, interfere with the subject's participation
for the full duration of the trial, or is not in the best interest of the subject to
participate, in the opinion of the site investigator
- Pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial
- Active central nervous system (CNS) metastases (if symptomatic or without prior brain
imaging, subjects must undergo a head computed tomography [CT] scan or brain magnetic
resonance imaging [MRI] within 28 days prior to registration for protocol therapy to
exclude brain metastases)
- Treatment with any investigational agent within 28 days prior to registration for
protocol therapy
- Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than
standard concurrent chemoradiation or up to 2 cycles of consolidation therapy
- Active second cancers
- History of psychiatric illness or social situations that would limit compliance with
study requirements
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.