CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
FOLFOXIRI +3 moredrug
Likely dose
FOLFOXIRI 85mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04380337
NCT04380337Phase 2Completed
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Phase II Trial of Organ Preservation Program Using Short-Course Radiation and FOLFOXIRI for Rectal Cancer (SHORT-FOX)

Stanford University·interventional·Posted May 8, 2020·Updated Feb 25, 2025

In Brief

A Phase 2 clinical trial evaluating FOLFOXIRI, FOLFOX regimen, and 2 other interventions for Rectal Cancer. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of the research is to evaluate whether both chemotherapy and radiotherapy can lead to higher rates of clinical complete response leading to organ preservation in human subjects with cancer. The objective is to learn if this treatment approach may safely be used as an alternative to the standard treatment for rectal cancer and to know the quality-of-life in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 8, 2020
Enrollment StartMay 21, 2020
Primary CompletionJan 17, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.1 years ago

Interventions

FOLFOXIRIdrug

Chemotherapy regimen of Oxaliplatin 85mg/m2 , Leucovorin 400 mg/m2 , Irinotecan 165mg/m2 , 5-Fluorouracil

FOLFOX regimendrug

Chemotherapy regimen of Oxaliplatin 85mg/m2, Leucovorin 400 mg/m2, 5-Fluorouracil 2400mg/m2

XELOXdrug

Chemotherapy regimen of Oxaliplatin 130 mg/m2, Capecitabine 1000mg/m2

IMRTradiation

Radiotherapy (5 Gy x 5 fractions) with an additional boost fraction (5 Gy x 1 fraction) delivered sequentially