43
Participants
Start Date
November 16, 2018
Primary Completion Date
July 17, 2025
Study Completion Date
December 31, 2027
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
Paclitaxel
"Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered~* the dose is 45 mg/m2 (standard dose)~* Administered weekly~* 6 to 7 weeks of therapy, depending on when radiation starts~* Standardized dose reductions are used"
Carboplatin
"Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.~* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)~* Administered weekly~* 6 to 7 weeks of therapy, depending on when radiation starts~* Standard dose reductions are used"
Ascorbic Acid
"Administered intravenously~* 75 grams per infusion; each infusion is about 2 hours~* 3 infusion per calendar week~* The infusion is actively running for at least 20 minutes when radiation begins~* May be given while chemotherapy is delayed due to low counts~* Dose reductions are not used~* Given for 6 to 7 weeks, depending on when radiation starts"
Holden Comprehensive Cancer Cener, Iowa City
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Holden Comprehensive Cancer Center
OTHER
Joseph J. Cullen, MD, FACS
OTHER