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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30CA086862 | U.S. NIH Grant/Contract | View source | |
| 5U01CA140206 | U.S. NIH Grant/Contract | View source | |
| 1P01CA217797-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| Holden Comprehensive Cancer Center | OTHER |
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This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.
For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy."
This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm.
Participants will:
This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need.
However, it is very important the investigators remain in contact with participants; they will have life-long follow-up for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChemoRT + Ascorbate | Experimental | Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Drug | Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression rate at completion of radiation and chemotherapy | Tumor measurement from CT scan, using the RECIST criteria to define progression | 3 to 4 weeks after last radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | From radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. | Every six months for up to 20 years post-treatment |
| Progression free survival (PFS) |
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Inclusion Criteria:
Note: 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
Exclusion Criteria:
Exudative pleural effusion
Recurrent non-small cell lung cancer
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients actively receiving insulin or patients whose doctors have recommended current insulin use
Patients requiring daily finger-stick blood glucose measurements
Patients who are on the following drugs and cannot have a substitution or who decline the substitution:
Prior radiation therapy that would result in a field overlap
Enrolled in another therapeutic clinical trial
Uncontrolled, intercurrent illness
Lactating women
HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy
If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Cullen, MD, FACS | University of Iowa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Cener | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28366679 | Background | Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2â‹…- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30. |
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Individual participant data will be shared upon request in compliance with the IRB application and protocol.
Upon request.
Contact the investigator or sub-investigator to initiate a request. A contract may be required between institutions. Data will be shared only from those participants who consented to sharing.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2025 | Dec 18, 2025 |
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| Paclitaxel | Drug | Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
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| Carboplatin | Drug | Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
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| Ascorbic Acid | Drug | Administered intravenously
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Time, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression |
| Every six months for up to 20 years post-treatment |
| Overall survival (OS) | Time, measured in months, from start of radiation to death from any cause. | Every three months for up to 20 years post-treatment |
| Adverse event frequency and categorization | Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows:
| Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment |
| ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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