Supplementation of L-arginine in Patients With Non-resectable Brain Metastases

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

November 30, 2007

Study Completion Date

December 31, 2008

Conditions
Unresectable Multiple Brain Metastases
Interventions
DIETARY_SUPPLEMENT

L-arginine hydrochloride solution

Patients with unresectable brain metastases from solid tumors that are candidates from twice-daily fractionated radiation therapy will be randomized to receive either oral arginine supplementation one-hour prior to each fraction of radiation. Radiation therapy consist in whole-brain treated by two lateral fields to a total dose of 32 Gy in 20 fractions of 1.6 Gy each two times a day with a 6 hours interval between treatments (10 days), followed by a 22.4 Gy boost over the evident lesions with the same fractionation schedule (7 days). The spinal cord dose will be limited to 40 Gy

OTHER

Placebo

Patients with unresectable brain metastases from solid tumors that are candidates from twice-daily fractionated radiation therapy will be randomized to receive oral placebo one-hour prior to each fraction of radiation. Radiation therapy consist in whole-brain treated by two lateral fields to a total dose of 32 Gy in 20 fractions of 1.6 Gy each two times a day with a 6 hours interval between treatments (10 days), followed by a 22.4 Gy boost over the evident lesions with the same fractionation schedule (7 days). The spinal cord dose will be limited to 40 Gy

All Listed Sponsors
lead

Instituto de Oncología Ángel H. Roffo

OTHER

NCT02844387 - Supplementation of L-arginine in Patients With Non-resectable Brain Metastases | Biotech Hunter | Biotech Hunter