Clinical Trial: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Brief 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.

Detailed Summary:

Local control in sinonasal malignancies is dose dependent. However, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/ design:

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and late toxicity at 2 years post RT)are secondary endpoints.


Sponsor: Heidelberg University

Current Primary Outcome: mucositis CTC grade 3 [ Time Frame: 6-8 weeks post completion of treatment ]

Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • local control [ Time Frame: 2 years post completion of RT ]
  • disease-free survival [ Time Frame: 2 years post completion of RT ]
  • overall survival [ Time Frame: 2 years post completion of RT ]
  • acute toxicity CTC grade 1/2 [ Time Frame: within 90 days of RT ]
  • late toxicity [ Time Frame: from 90 days to trial completion ]


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: October 12, 2010
Date Started: November 2010
Date Completion: November 2016
Last Updated: April 23, 2013
Last Verified: April 2013