A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC — XACT-LUNG  

Non-Small Cell Lung Cancer Clinical Trial

Official title: A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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:

• 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Non-Small-Cell Lung Carcinoma
• Nonsmall Cell Lung Cancer
• NSCLC

• NCT number: NCT02905591
• Study type: Interventional
• Source: University of Iowa
• Contact: Bryan G Allen, MD, PhD
• Phone: 319-353-8836
• Email: bryan-allen@uiowa.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: November 16, 2018
• Completion date: December 31, 2027