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

NCT03094884 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: RT-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.

  The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).

  2 years

Secondary Outcomes (3)

• Quality of life

  1 year

• Progression free survival

  1-5 years

• Response rate based

  1 year

Study Arms (1)

Pulsed Low dose radiation with Carboplatin/Paclitaxel

EXPERIMENTAL

Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel

Radiation: Pulsed Low Dose Radiation; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Pulsed Low Dose Radiation 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.

Pulsed Low dose radiation with Carboplatin/Paclitaxel

Carboplatin DRUG

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.

Pulsed Low dose radiation with Carboplatin/Paclitaxel

Paclitaxel DRUG

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.

Pulsed Low dose radiation with Carboplatin/Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Carboplatin-Paclitaxel followed by surgery.
• Age \> 18 years.
• 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 of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
• Patients must be able to read and write English to comply with the questionnaire portions of the protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Interventions

Heart Rate; Radiation; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Physical Phenomena; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Joshua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Meyer, MD

CONTACT

215-214-1515; joshua.meyer@fccc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: February 24, 2017
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)