A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (XACT-LUNG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02905591|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Non-Small-Cell Lung Carcinoma NSCLC||Drug: Radiation Therapy Drug: Paclitaxel Drug: Carboplatin Drug: Ascorbic Acid||Phase 2|
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.
- receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered.
- undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays.
- provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2026|
Experimental: ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Drug: Radiation Therapy
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
Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
Drug: Ascorbic Acid
- Progression rate at completion of radiation and chemotherapy [ Time Frame: 3 to 4 weeks after last radiation treatment ]Tumor measurement from CT scan, using the RECIST criteria to define progression
- Tumor response [ Time Frame: Every six months for up to 20 years post-treatment ]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.
- Progression free survival (PFS) [ Time Frame: Every six months for up to 20 years post-treatment ]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
- Overall survival (OS) [ Time Frame: Every three months for up to 20 years post-treatment ]Time, measured in months, from start of radiation to death from any cause.
- Adverse event frequency and categorization [ Time Frame: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment ]
Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows:
- Through radiation, weekly assessment of adverse events
- Consolidation chemotherapy, assessment day 1 of each cycle
- Post-treatment, every 6 months through 2 years post-therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905591
|Contact: Bryan G Allen, MD, PhDfirstname.lastname@example.org|
|Contact: Muhammad Furqan, MDemail@example.com|
|United States, Iowa|
|Holden Comprehensive Cancer Cener||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sandy Vollstedt, RN, BSN, OCN 319-353-7143 firstname.lastname@example.org|
|Contact: Heather Brown, RN, BAN, OCN 319-384-7912 email@example.com|
|Principal Investigator: Bryan G Allen, MD, PhD|
|Principal Investigator: Muhammad Furqan, MD|
|Study Director:||Joseph J Cullen, MD, FACS||University of Iowa|