NCT05733910

Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma

Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: CNAO National Center of Oncological Hadrontherapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim at investigating in a prospective clinical trial whether using a Simoultaneous Integrated Boost of carbon ions treatment planning approach, improving the tumor dose conformation while lowering the unintended dose to the low-risk volume, can significantly reduce the probability of toxicity without affecting Local Control.

Detailed description

In photon radiotherapy, Simultaneous integrated boost (SIB)-intensity-modulated radiation therapy (IMRT) with slight hypofractionation in the HR-CTV is the current standard of care, being previously largely adopted in clinical practice and within several prospective clinical trials, with similar results in terms of toxicity and oncologic outcome. Up to now, a simultaneous integrated boost (SIB) approach has not been fully exploited in CIRT so far. The expected benefit of a SIB planning approach in carbon ion treatment is the reduction of toxicity with respect to the sequential (SEQ) approach currently used in CNAO clinical practice, while maintaining the same local control rate. This benefit depends on the potentiality of SIB to better spare normal tissues, further enhancing the intrinsic favourable physical and radiobiological characteristics of the carbon ions.

Conditions

• Carcinoma, Adenoid Cystic
• Head and Neck Cancer

Interventions

Type	Name	Description
RADIATION	simultaneous integrated boost of carbon ions radiation therapy	CIRT Treatment will be delivered in 16 fractions, 4 fractions per week. Treatment plans will be calculated with a Simultaneous Integrated Boost Approach (SIB). The HR-CTV will receive a total dose of 65.6 GyRBE (4.1 GyRBE/fraction). The LR-CTV will simultaneously receive a total dose of 54.4 GyRBE (3.4 GyRBE/fraction) or 48 GyRBE (3 GyRBE/fraction) at discretion of Radiation Oncologist depending on the prognostic factors (54.4 GyRBE in case of macroscopical perineural invasion or positive margin along the nerve, 48.0 Gy(RBE) in case of elective perineural irradiation or microscopic focal intratumor perineural invasion).

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-02-27
• Completion: 2026-11-28
• First posted: 2023-02-17
• Last updated: 2025-02-13

Locations

1 site across 1 country: Italy