CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Temozolomidedrug
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/NCT01781403
NCT01781403Phase 1Completed
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Preoperative Chemoradiation With Capecitabine Plus Temozolomide in Patients With Locally Advanced Resectable Rectal Cancer: Phase I Study

Asan Medical Center·interventional·Posted Feb 1, 2013·Updated Feb 4, 2021

In Brief

A Phase 1 clinical trial evaluating Temozolomide for Rectal Cancer. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The investigators planned a phase I study of preoperative CRT with capecitabine plus temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in 20\~40% of colorectal cancer patients, and this proportion could be adequate for validation as its role of predictive biomarker, and 3) temozolomide can be additive or synergistic because radiotherapy is now essential in the treatment of rectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2013
Enrollment StartMay 10, 2013
Primary CompletionSep 3, 2014
Study CompletionMay 4, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago

Interventions

Temozolomidedrug

Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD.