Alkylating agents
Radiation Therapy for Non-Small Cell Lung Cancer
Holden Comprehensive Cancer Cener, Iowa City, IA
Targeting 2 different conditionsRadiation Therapy +3 morePhase 2RecruitingResearch Sponsored by Joseph J. Cullen, MD, FACSEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible
Recommended to receive carboplatin & paclitaxel with radiation therapy as a treatment
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upweekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Study Summary
This trial is testing whether adding high doses of vitamin C to standard radiation and chemotherapy treatment for lung cancer improves outcomes.
Eligible Conditions
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You may still participate in the trial if you have a small amount of fluid around your lungs that is too little to safely remove and cannot be seen on a chest x-ray.
Select...
You are currently being treated with carboplatin, paclitaxel, and radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression rate at completion of radiation and chemotherapy
Secondary outcome measures
Adverse event frequency and categorization
Overall survival (OS)
Progression free survival (PFS)
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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: ChemoRT + AscorbateExperimental Treatment4 Interventions
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Ascorbic acid
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Paclitaxel
FDA approved
Find a site
Who is running the clinical trial?
Joseph J. Cullen, MD, FACSLead Sponsor
3 Previous Clinical Trials
128 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,611 Previous Clinical Trials
6,804,844 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,402 Previous Clinical Trials
41,225,295 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
25 Previous Clinical Trials
732 Total Patients Enrolled
Joseph J Cullen, MD, FACSStudy Director
University of Iowa1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what instances is Radiation Therapy regularly employed?
"Radiation Therapy is a viable method of treating malignant tumours, chronic congestion and vitamin insufficiency."
Answered by AI
Have any other endeavors studied the effects of Radiation Therapy?
"Presently, there are 1,224 active studies for Radiation Therapy with 340 trials in their final phase. Shanghai is the epicentre of these clinical trials; however they are being conducted across 69,980 different sites worldwide."
Answered by AI
What measures are being taken to ensure the safety of radiation treatments?
"Our team at Power rated Radiation Therapy's safety as a 2 due to the lack of evidence regarding efficacy, although some data exists that supports its safety."
Answered by AI
How many participants are actively enrolled in this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this medical experiment, which was first uploaded on November 16th 2018 is actively sourcing patients for participation. Specifically 46 participants are needed from 1 clinical site."
Answered by AI
Are there any available slots remaining in this research protocol?
"Clinicaltrials.gov reports that this study is actively looking for patients; the trial was listed on November 16th, 2018 and last updated on August 12th 2022."
Answered by AI