drugset / Trial / NCT02319304

Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma

NCT02319304 ↗

Phase 2 Terminated 3 enrolled University of Maryland, Baltimore
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the first two days of each cycle.

Timeline

Start
2015-03
Primary completion
2018-10-05
Completion
2018-10-05

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual, PI left instituion”

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications