Recruiting
Phase 1

Pulsed LDR Radiation & Chemotherapy

Sponsor:

Fox Chase Cancer Center

Code:

NCT03094884

Conditions

Lung Cancer

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulsed Low Dose Radiation

Carboplatin

Paclitaxel

Study Details

Brief 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.

Conditions

Lung Cancer

Esophageal Cancer

Study ID

NCT03094884

Start date

Feb 24, 2017

Status verified date

May, 2023

Completion date

May 1, 2025

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulsed Low dose radiation with Carboplatin/Paclitaxel

Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel

Interventions

Pulsed Low Dose Radiation

Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.

Carboplatin

Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.

Paclitaxel

Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.

Primary outcome measure

  • Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

May 23, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2023-05-23.