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Alkylating agents
Vitamin C with Chemotherapy and Radiation for Lung Cancer (XACT-LUNG Trial)
Phase 2
Recruiting
Research Sponsored by Joseph J. Cullen, MD, FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min*1.73m2)
Pathologic diagnosis of non-small cell lung cancer
Timeline
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
Awards & highlights
XACT-LUNG Trial Summary
This trial is testing whether adding high doses of vitamin C to standard radiation and chemotherapy treatment for lung cancer improves outcomes.
Who is the study for?
This trial is for adults with non-small cell lung cancer who are healthy enough for chemotherapy and radiation, have a measurable tumor of at least 1 cm by CT or MRI, and not pregnant. They must have normal platelet counts and kidney function, no severe pleural effusion, no G6PD deficiency, not on certain medications like warfarin or insulin, and not HIV positive on antiretroviral therapy.Check my eligibility
What is being tested?
The study tests adding high-dose vitamin C (ascorbate) to the standard treatment regimen of carboplatin and paclitaxel chemotherapy combined with radiation therapy. All participants will receive this additional ascorbate alongside their prescribed treatments.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss; radiation therapy like skin irritation; plus any unique reactions to high doses of vitamin C which could range from digestive discomfort to possible interference with blood sugar levels.
XACT-LUNG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function tests are within the required range.
Select...
I have been diagnosed with non-small cell lung cancer.
Select...
My lung cancer can be seen and measured on a scan.
XACT-LUNG Trial 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 moreXACT-LUNG 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
Paclitaxel
FDA approved
Carboplatin
FDA approved
Ascorbic acid
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,830 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,808 Total Patients Enrolled
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
731 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking one of the specified drugs and cannot or will not switch to a different one.My kidney function tests are within the required range.I have fluid buildup in the lining of my lungs.I have G6PD deficiency.I have had radiation therapy in the same area before.I do not have any uncontrolled illnesses.I am HIV positive and on treatment that might interact with high-dose vitamin C.I have a small fluid collection in my chest that can't be safely removed and isn't seen on an X-ray.The tumor or cancer spread needs to be at least 1 cm in size as seen on a CT scan.You need to have at least 100,000 platelets per milliliter of blood.I am advised to get carboplatin & paclitaxel with radiation.My lung cancer has come back after treatment.I have been diagnosed with non-small cell lung cancer.You need to check your blood sugar every day by pricking your finger.My doctor says I'm fit for chemotherapy and radiation.My lung cancer can be seen and measured on a scan.I am currently using insulin as recommended by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: ChemoRT + Ascorbate
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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
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