Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | February 24, 2017 |
| End Date: | November 1, 2021 |
| Contact: | Joshua Meyer, MD |
| Email: | joshua.meyer@fccc.edu |
| Phone: | 215-214-1515 |
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.
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.
Inclusion Criteria:
1. 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.
2. The planned treatment regimen must be concurrent chemoradiation with
Carboplatin-Paclitaxel followed by surgery.
3. Age > 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
5. 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
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.
7. Patients must be able to read and write English to comply with the questionnaire
portions of the protocol.
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.
Exclusion Criteria:
1. Patients who have had previous radiotherapy in the thorax.
2. Patients who have a history of ataxia telangiectasia or other documented history of
radiation hypersensitivity.
3. Patients who have a history scleroderma or other active connective tissue disease.
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. 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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