Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]
2 other identifiers
interventional
3
1 country
1
Brief Summary
This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedStudy Start
First participant enrolled
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2023
CompletedOctober 29, 2024
July 1, 2023
2.7 years
June 23, 2020
October 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of severe unacceptable local adverse events which are radio therapeutically attributable
Specifically, Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade =\< 3 in 3 months, and CTCAE version 5 grade \>= 3 myelopathy, and/or osteonecrosis. Summary statistics, including mean, standard deviation and 95% confidence interval will be used to describe safety data. Toxicity will be tabulated and summarized by grade and type.
Up to 6 months after radiation therapy
Secondary Outcomes (1)
Incidence of grade 3 toxicity
At 3-6 months after radiation therapy
Study Arms (1)
Treatment (proton therapy)
EXPERIMENTALPatients undergo radiation therapy QD 5 days a week (Monday through Friday) for the first 18 days and then BID for 15 days in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo radiation therapy
Ancillary studies
Eligibility Criteria
You may qualify if:
- Biopsy proven diagnosis of squamous cell carcinoma of head and neck cancer originating in the oropharynx, hypopharynx, larynx, oral cavity (base of tongue) or nasopharynx. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the image tumor characteristic of the primary tumor
- Negative for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
- Inoperable locally advances disease, i.e. stage \>= III and T stage \>= 2
- The primary radiotherapy, either in combination with chemotherapy or not, with curative intent
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
- For females of child-bearing age, a negative pregnancy test
You may not qualify if:
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their head and neck squamous cell carcinoma (HNSCC)
- Patient that refuse or are unable to stop smoking and/or consuming alcohol during and after radiotherapy. In addition, patients that refuse or fail tobacco and alcohol blood test
- Patients that have no detectable no tumor in both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost
- Patients unable or unwilling to give written, informed consent or to undergo magnetic resonance imaging (MRI) imaging
- Women of childbearing potential (a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]). Male partners must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
- Patients unable to tolerate intravenous contrast for both computed tomography (CT) and MRI, having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m\^2 or any contraindications to gadolinium-based contrast agents
- Contraindications to iron supplementation include hemochromatosis, colitis, history of gastrointestinal (GI) bleeds, alcoholism, or liver disease. Ferumoxytol is contraindicated in patients with evidence of iron overload and/or known hypersensitivity to Feraheme or any of its components. Consequently, we will plan to exclude patients who have symptoms or signs that might be caused by iron overload. These include patients with (unexplained): arthritis (including premature osteoarthritis), congestive heart failure or cardiomyopathy, adult-onset diabetes, secondary hypogonadism, increased skin pigmentation, or patients with persistently elevated serum ferritin not explained by an underlying inflammatory/systemic disease, unless these patients demonstrate a fasting transferrin saturation =\< 0.45
- Patients with any evidence of iron overload on pre-imaging laboratory studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
van Dijk LV, Frank SJ, Yuan Y, Gunn B, Moreno AC, Mohamed ASR, Preston KE, Qing Y, Spiotto MT, Morrison WH, Lee A, Phan J, Garden AS, Rosenthal DI, Langendijk JA, Fuller CD. 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 of MRI-guided adaptive particle radiotherapy. Clin Transl Radiat Oncol. 2021 Nov 11;32:35-40. doi: 10.1016/j.ctro.2021.11.003. eCollection 2022 Jan.
PMID: 34841093DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clifton D Fuller
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
May 4, 2021
Study Start
October 19, 2020
Primary Completion
July 11, 2023
Study Completion
July 11, 2023
Last Updated
October 29, 2024
Record last verified: 2023-07