CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Boost radiationradiation
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/NCT01627288
NCT01627288N/ACompleted
CompareCT.gov

Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

Duke University·interventional·Posted Jun 25, 2012·Updated Feb 8, 2021

In Brief

A clinical study evaluating Boost radiation for Cancer of the Cervix and Cervical Neoplasms. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of the Cervix, Cervical Neoplasms
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2012
Enrollment StartJun 4, 2012
Primary CompletionNov 16, 2018
Study CompletionNov 16, 2019
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 14.0 years ago

Interventions

Boost radiationradiation

Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy