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Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12) (IMRT-HIT-SNT)

Primary Purpose

Sinonasal Malignancies, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

carbon ion boost

About this trial

This is an interventional treatment trial for Sinonasal Malignancies focused on measuring IMRT, carbon ion therapy, paranasal sinus, nasal cavity, adenocarcinoma, squamous cell carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses
Inoperable tumour or refusal to undergo surgical resection
Macroscopic or microscopic residual tumour (R2/ R1) or
≥T3/T4 or
written informed consent
pts aged 18 - 80 years
effective contraception for pts in childbearing age (<12 months post beginning of menopause)

Exclusion Criteria:

Prior radio- or chemotherapy for tumours of the head and neck
Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
Legal incapacity or limited legal capacity
Positive serum/ urine beta-HCG/ pregnancy
Drug abuse

Sites / Locations

Dept of Radiation Oncology, University of Heidelberg, INF 400

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT + carbon ion boost

Arm Description

(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.

Outcomes

Primary Outcome Measures

mucositis CTC grade 3

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

Secondary Outcome Measures

local control

disease-free survival

overall survival

acute toxicity CTC grade 1/2

late toxicity

Full Information

NCT ID

NCT01220752

First Posted

October 12, 2010

Last Updated

August 29, 2022

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT01220752

Brief Title

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

Acronym

IMRT-HIT-SNT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

June 17, 2011 (Actual)

Primary Completion Date

August 29, 2019 (Actual)

Study Completion Date

December 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

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 Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinonasal Malignancies, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses

Keywords

IMRT, carbon ion therapy, paranasal sinus, nasal cavity, adenocarcinoma, squamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMRT + carbon ion boost

Arm Type

Experimental

Arm Description

(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.

Intervention Type

Radiation

Intervention Name(s)

carbon ion boost

Intervention Description

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

Primary Outcome Measure Information:

Title

mucositis CTC grade 3

Description

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

Time Frame

6-8 weeks post completion of treatment

Secondary Outcome Measure Information:

Title

local control

Time Frame

2 years post completion of RT

Title

disease-free survival

Time Frame

2 years post completion of RT

Title

overall survival

Time Frame

2 years post completion of RT

Title

acute toxicity CTC grade 1/2

Time Frame

within 90 days of RT

Title

late toxicity

Time Frame

from 90 days to trial completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses Inoperable tumour or refusal to undergo surgical resection Macroscopic or microscopic residual tumour (R2/ R1) or ≥T3/T4 or written informed consent pts aged 18 - 80 years effective contraception for pts in childbearing age (<12 months post beginning of menopause) Exclusion Criteria: Prior radio- or chemotherapy for tumours of the head and neck Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators Legal incapacity or limited legal capacity Positive serum/ urine beta-HCG/ pregnancy Drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juergen Debus, MD PhD

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Radiation Oncology, University of Heidelberg, INF 400

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

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

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