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Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial

Proton Image-guided Radiation Assignment for Therapeutic Escalation via Selection of locally advanced head and neck cancer patients [PIRATES]: A Phase I safety and feasibility trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24790
Enrollment
18
Registered
2021-07-15
Start date
2021-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Head and Neck Cancer (HPV-negative)

Interventions

Radiation dose escalation with image-guided hybrid hyper-fractionated with proton therapy, while sparing the mucosal and bone structures

Sponsors

MD Anderson Cancer Center; NWO
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Biopsy proven diagnosis of squamous cell carcinoma of HNC originating in the oropharynx, hypopharynx, larynx, or oral cavity (base of tongue) • The primary radiotherapy with curative intend, either in combination with chemotherapy or not • Inoperable locally advanced disease, defined as: • AJCC 8th stage = III • T stage =2 • Negative for HPV by p16 IHC or ISH

Exclusion criteria

Exclusion criteria: • Previous radiation treatment in the head and neck region • Head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies • Pregnant or breast-feeding females • Patients younger than 18 years • Patients with ECOG performance score of 2 or lower • Contraindications to MRI • Patients that continue to smoke or abuse alcohol during treatment

Design outcomes

Primary

MeasureTime frame
Severe unacceptable local adverse events which are radiotherapeutically attributable. Specifically, CTCAEv5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =3 in 3 months, and CTCAEv5 grade=3 myelopathy, and/or osteonecrosis.

Secondary

MeasureTime frame
Rates of grade 3 toxicity in 3 to 6 months after radiation oncology. Specifically, CTCAEv5 grade 3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain.

Contacts

Public ContactLisanne van Dijk

MD Andeson Cancer Center

lvvan@mdanderson.org+31655257381

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)