CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
FOLFOX regimen +2 moredrug
Likely dose
Not stated in 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/NCT03904043
NCT03904043N/ACompleted
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Non-Operative Management and Early Response Assessment in Rectal Cancer

Washington University School of Medicine·interventional·Posted Apr 4, 2019·Updated May 1, 2026

In Brief

A clinical study evaluating Radiation therapy, FOLFOX regimen, and 1 other intervention for Adenocarcinoma of the Lower Rectum. Completed, enrolled 63 participants across 4 sites.

Detailed Summary

The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Lower Rectum
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 4, 2019
Enrollment StartJul 1, 2020
Primary CompletionAug 21, 2024
Study CompletionJan 25, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.2 years ago

Interventions

Radiation therapyradiation

-Monday-Friday treatment is strongly recommended

FOLFOX regimendrug

-CAPOX can be given as alternative

CAPOX regimendrug

Given as an alternative to FOLFOX