Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer
The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.
Paarticipants will receive a single fraction of LEAD radiation on day 1, followed one day
later by conventionally fractionated concurrent chemoradiation consisting of 60 Gy of
radiation delivered to involved sites of disease and a platinum doublet.
The investigational radiation treatment, a single fraction of LEAD radiation, is to be
followed by conventionally fractionated radiation delivered concurrently with a standard
chemotherapy regimen for stage III non-small cell lung cancer. The following day, patients
will begin concurrent chemotherapy and radiation. Chemotherapy will be delivered under the
management of the treating medical oncologist. Chemotherapy must be a platinum doublet.
Carboplatin and cisplatin are both considered acceptable platinum agents. The use of
cisplatin over carboplatin is strongly encouraged, unless the patient has a contraindication
to cisplatin. The second agent will be at the discretion of the treating medical oncologist;
in the current era, chemotherapy agents are tailored to each patient based on tumor
histology, as well as comorbidities that dictate the tolerance of certain chemotherapeutic
agents. Chemotherapy will be delivered concurrently throughout radiation therapy, beginning
on day 2 of the treatment protocol and on the same day as the start of standard-dose
radiation. Weekly regimens or regimens delivered every 3 weeks are acceptable. Additional
cycles of consolidation chemotherapy are encouraged and will be given at the discretion of
the treating medical oncologist.
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