CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 12 enrolled / 12 target
Drug / intervention
FOLFOXdrug
Likely dose
FOLFOX 85 mgfrom 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/NCT03781323
NCT03781323Phase 2ActiveUpdate Overdue (0.1/mo)Completion was 49mo ago
CompareCT.gov

Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer: A Phase II Study

University of Rochester·interventional·Posted Dec 19, 2018·Updated Jun 4, 2026

In Brief

A Phase 2 clinical trial evaluating FOLFOX for Advanced Rectal Cancer. Active but no longer recruiting, targeting 12 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Rectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedDec 19, 2018
Enrollment StartMay 3, 2019
Primary CompletionJun 1, 2022
Study CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.5 years ago

Arms & Interventions

mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)experimental

Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.

Drug: FOLFOX

Interventions

FOLFOXdrug

Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.