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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
Secondary outcome measures
Progression free survival
Quality of life
Response rate based
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
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,498 Total Patients Enrolled
Joshua Meyer, MDPrincipal InvestigatorFox Chase Cancer Center
6 Previous Clinical Trials
183 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.You have a history of scleroderma or other ongoing connective tissue disease.I have a history of extreme sensitivity to radiation or ataxia telangiectasia.I am not pregnant, not breastfeeding, and if of childbearing age, have a recent negative pregnancy test.I have untreated Stage IIIA non-small cell lung cancer or localized esophageal cancer.My treatment plan includes chemoradiation with Carboplatin-Paclitaxel and then surgery.I agree to use effective birth control during and for 3 months after the study.Your blood tests need to show certain levels: a certain number of white blood cells, platelets, and hemoglobin, as well as specific levels of creatinine, bilirubin, and AST.I am fully active or can carry out light work.I have had radiation therapy in my chest area before.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed Low dose radiation with Carboplatin/Paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently recruiting participants?
"Per the information on clinicaltrials.gov, this clinical trial is currently recruiting subjects. It was initially posted on February 24th 2017 and has subsequently been updated as recently as February 18th 2022."
Answered by AI
Are there any potential hazards associated with Pulsed Low Dose Radiation treatments?
"As the study is at Phase 1, review of safety and efficacy data is limited. Consequently, our team has assigned Pulsed Low Dose Radiation a score of 1 on their scale."
Answered by AI
How many participants are permitted in this experiment?
"Affirmative. The details posted on clinicaltrials.gov confirms that this research endeavour, which was initially published on February 24th 2017, is actively recruiting patients. 40 participants are needed to be enrolled from one hospital site."
Answered by AI
Are there any prior studies that have looked into the effect of Pulsed Low Dose Radiation?
"Currently, 1174 clinical trials are being conducted to research the efficacy of Pulsed Low Dose Radiation, with 332 currently in Phase 3. Although most studies are based out of Shanghai, over 65 thousand medical centres across the globe have been conducting these trials."
Answered by AI
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