Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    40
  • sponsor
    Fox Chase Cancer Center
Updated on 8 March 2022
paclitaxel
cancer
total bilirubin
absolute neutrophil count
lung cancer
definitive treatment
metastasis
chemoradiotherapy
neutrophil count
carboplatin
esophageal cancer
concurrent chemotherapy
esophagus cancer
ebrt
carboplatin/paclitaxel
lung carcinoma

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.

Details
Condition Lung Cancer, Esophageal Cancer
Treatment carboplatin, Paclitaxel, Pulsed Low Dose Radiation
Clinical Study IdentifierNCT03094884
SponsorFox Chase Cancer Center
Last Modified on8 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must have pathologically-confirmed and previously untreated
Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging
The planned treatment regimen must be concurrent chemoradiation with
Age > 18 years
Carboplatin-Paclitaxel followed by surgery
Eastern Cooperative Oncology Group (ECOG) performance status is 0-1
Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration)
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Platelets ≥100,000 cells/mm3
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
Creatinine ≤2 X the upper limit of normal
Bilirubin ≤ 1.5 X upper limit of normal
Aspartate transaminase (AST) ≤ 3 X upper limit of normal
Men and women of childbearing potential must be willing to exercise an effective form
Patients must be able to read and write English to comply with the questionnaire portions of the protocol
of birth control (abstinence/contraception) while on study and for 3 months
Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
after therapy completed

Exclusion Criteria

Patients who have had previous radiotherapy in the thorax
Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Patients who have a history scleroderma or other active connective tissue disease
Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
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