AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART)

NCT05081531 | Active Not Recruiting

• 1 other identifier: 2986
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Radical RT, exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines. Despite the recent technological advancements in the field of RT, about 30-50% of patients will develop locoregional failure after primary treatment . Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life. The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic. With ART we mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment. Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as input features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization. The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigators designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Locoregional recurrence free survival

  Locoregional recurrence free survival in head and neck cancer patients treated with adaptive radiotherapy

  1 year

Secondary Outcomes (2)

• Progression Free Survival

  1 year

• Overall Survival

  1 year

Study Arms (1)

Adaptive Radiotherapy in Head and Neck cancer patients

OTHER

Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week. At week 3 from RT start, patients will repeat contrast simulation CT with, and MRI and FDG-PET scan for treatment replanning. Patient will start with the new plan in week 4.

Radiation: Adaptive Radiotherapy

Interventions

Adaptive Radiotherapy RADIATION

All the patients will be treated with VMAT technique in its RapidArc form. A simultaneous integrated boost (SIB) technique will be used. The GTV will encompass the tumor delineated on CT scan, adjusted for MRI and PET scans. Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week.

Adaptive Radiotherapy in Head and Neck cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG Performance status 0 to 2
• Life expectancy \> 12 months
• Histological proven squamous cell carcinoma of the pharynx, larynx or oral cavity
• Locally advanced stage disease classified as T3-T4 or N1-3
• Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
• Visible disease at the primary site on imaging performed within 4 weeks of starting treatment
• Adequate liver function
• Adequate renal function for infusion of iv. contrast for CT-scan and MRI-scan
• Adequate bone marrow function
• Written informed consent
• No previous radiation therapy on head and neck region

You may not qualify if:

• Inability to provide informed consent
• Presence of distant metastases
• Previous radiation therapy on head and neck region
• Pregnant or breastfeeding patients
• Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
• Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
• Allergy or contraindication to contrast agents
• General contraindications to MRI
• ECOG PS \>=3

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Clinical institute

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: October 5, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-04

Locations

IT (1)