Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery
technique can significantly decrease the rate of severe acute esophagitis in patients
receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or
esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe
acute esophagitis during concurrent CRT is high (approximately 20%) when conventional
external beam radiation is utilized. Severe acute esophagitis can cause many adverse
consequences such as severe discomfort, weight loss, hospitalization, interruption/early
termination of treatment, and worse surgical complications for those who receive surgery
after CRT. PLDR radiation has the potential to maintain the tumor control rates of
conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.
We have completed accrual to a phase I PLDR radiation study, in which patient received
palliative re-irradiation with PLDR technique for their metastatic disease in previous
irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the
setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The
follow up time for that phase I study is limited as most enrolled patients have short overall
survival due to their terminal illness.
This proposed phase I study is, to our knowledge, the first clinical study with combination
of PLDR radiation and concurrent chemotherapy for definitive treatment.