CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
concurrent chemotherapy +1 moredrug
Likely dose
concurrent chemotherapy 25mgfrom 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/NCT03900117
NCT03900117Phase 2Completed
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Hypofractionated Radiotherapy Followed by Hypofractionated Boost With Weekly Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: A Prospective, Single Arm Phase II Study

Sun Yat-sen University·interventional·Posted Apr 2, 2019·Updated Oct 27, 2022

In Brief

A Phase 2 clinical trial evaluating split-course radiotherapy and concurrent chemotherapy for Non-small Cell Lung Cancer. Completed, enrolled 77 participants across 1 site.

Detailed Summary

The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2, 2019
Enrollment StartMar 1, 2019
Primary CompletionJun 20, 2022
TodayJul 1, 2026
Enrollment to primary: 3.3 yearsPosted 7.2 years ago

Interventions

split-course radiotherapyradiation

Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor.

concurrent chemotherapydrug

Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.