RECRUITING

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

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Conditions

Lung CancerEsophageal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-02-24
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03094884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient must have pathologically-confirmed and previously untreated:
  2. * Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
  3. * Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging.
  4. 2. The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
  5. 3. Age \> 18 years.
  6. 4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
  7. 5. Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):
  8. * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  9. * Platelets ≥100,000 cells/mm3
  10. * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
  11. * Creatinine ≤2 X the upper limit of normal
  12. * Bilirubin ≤ 1.5 X upper limit of normal
  13. * Aspartate transaminase (AST) ≤ 3 X upper limit of normal
  14. 6. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
  15. 7. Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
  16. 8. 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.
  1. 1. Patients who have had previous radiotherapy in the thorax.
  2. 2. Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
  3. 3. Patients who have a history scleroderma or other active connective tissue disease.
  4. 4. 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
  5. 5. Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.

Contacts and Locations

Study Contact

Joshua Meyer, MD
CONTACT
215-214-1515
joshua.meyer@fccc.edu

Principal Investigator

Joshua Meyer, MD
PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

  • Joshua Meyer, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-24
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2017-02-24
Study Completion Date2025-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer
  • Esophageal Cancer