CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
carbon ion boostradiation
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/NCT01220752
NCT01220752Phase 2Completed
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Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Heidelberg University·interventional·Posted Oct 14, 2010·Updated Sep 1, 2022

In Brief

A Phase 2 clinical trial evaluating carbon ion boost for Sinonasal Malignancies and Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinonasal Malignancies, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2010
Enrollment StartJun 17, 2011
Primary CompletionAug 29, 2019
Study CompletionDec 19, 2021
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 15.7 years ago

Interventions

carbon ion boostradiation

8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks