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Alkylating agents

PLDR + Chemotherapy for Lung Cancer

Phase 1
Recruiting
Led By Joshua Meyer, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
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
Must not have
Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Patients who have had previous radiotherapy in the thorax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a Phase I study testing whether Pulsed Low Dose Radiation (PLDR) 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.

Who is the study for?
Adults over 18 with untreated non-small cell lung cancer (Stage IIIA) or localized esophageal cancer, who can undergo chemotherapy with Carboplatin-Paclitaxel followed by surgery. They must be in good physical condition (ECOG 0-1), able to read/write English for questionnaires, meet specific lab criteria for blood and organ function, use effective birth control, and consent to study procedures.
What is being tested?
This Phase I trial tests Pulsed Low Dose Radiation (PLDR) combined with chemotherapy (Carboplatin-Paclitaxel) against severe acute esophagitis in patients with lung or esophageal cancer. PLDR aims to reduce side effects compared to conventional radiation while maintaining treatment effectiveness.
What are the potential side effects?
Possible side effects include discomfort from acute esophagitis which may lead to weight loss, hospitalization, treatment interruption/termination. Chemotherapy could cause fatigue, nausea, low blood counts increasing infection risk; PLDR's goal is reducing these compared to standard radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have untreated Stage IIIA non-small cell lung cancer or localized esophageal cancer.
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My treatment plan includes chemoradiation with Carboplatin-Paclitaxel and then surgery.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of extreme sensitivity to radiation or ataxia telangiectasia.
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I have had radiation therapy in my chest area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
Secondary study objectives
Progression free survival
Quality of life
Response rate based

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulsed Low dose radiation with Carboplatin/PaclitaxelExperimental Treatment3 Interventions
Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,333 Total Patients Enrolled
Joshua Meyer, MDPrincipal InvestigatorFox Chase Cancer Center
6 Previous Clinical Trials
183 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03094884 — Phase 1
Lung Cancer Research Study Groups: Pulsed Low dose radiation with Carboplatin/Paclitaxel
Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03094884 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03094884 — Phase 1
~5 spots leftby Dec 2025
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