Reduced-Dose Radiotherapy for Head and Neck Cancer
(HN001 Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byChris McLaughlin, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Virginia
Must be taking: Chemotherapy
Must not be taking: Antineoplastic drugs
Disqualifiers: Metastatic disease, Prior radiotherapy, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can receive concurrent systemic anticancer therapy and investigational agents with approval. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of reduced-dose radiotherapy for head and neck cancer?
Research shows that Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) can improve treatment for head and neck cancer by better targeting tumors and preserving healthy tissue, leading to similar tumor control with fewer side effects compared to traditional methods. Intraoperative radiotherapy has also shown promise in controlling head and neck cancer with reasonable side effects, although more studies are needed to compare it with standard treatments.
12345Is reduced-dose radiotherapy for head and neck cancer generally safe for humans?
Reduced-dose radiotherapy, particularly using techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiation therapy (IGRT), is generally considered safe and can reduce side effects compared to traditional methods. However, some side effects like nausea and vomiting may still occur, and there are uncertainties about long-term effects such as secondary cancers and swallowing difficulties.
46789How is reduced-dose radiotherapy different from other treatments for head and neck cancer?
Reduced-dose radiotherapy, specifically using Intensity-Modulated Radiation Therapy (IMRT), is unique because it allows for precise targeting of the tumor while minimizing damage to surrounding healthy tissues. This approach can maintain effective tumor control while reducing side effects compared to conventional radiation therapy.
1491011Eligibility Criteria
This trial is for adults with HPV-positive squamous cell carcinoma of the oropharynx. They must be willing to use contraception, follow study procedures, and can receive other cancer treatments if approved. Excluded are those with distant metastasis, recent heart issues, severe infections or lung problems, liver dysfunction, AIDS, heavy tobacco history unless quit a year ago, current antineoplastic drug use for another cancer, prior head/neck radiation or another invasive malignancy within 3 years.Inclusion Criteria
I am planning to undergo radiotherapy as my main or additional cancer treatment.
Provision of signed and dated informed consent form
I am able to get out of my bed or chair and move around.
+9 more
Exclusion Criteria
My cancer has spread to distant parts of my body.
Participant is a prisoner
Pregnancy or lactation
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Treatment
Participants receive a reduced dose of radiotherapy, with dosing determined by concurrent chemotherapy, HPV blood test results, physical exam, and imaging.
6-8 weeks
Routine visits for NavDx testing and treatment response assessment
Follow-up
Participants are monitored for safety, effectiveness, and disease progression after treatment
6 months to 1 year
Regular follow-up visits for safety and effectiveness evaluation
Long-term Follow-up
Participants are monitored for long-term survival and disease progression
up to 5 years
Participant Groups
The trial tests a lower dose of radiation therapy on patients with head and neck squamous cell carcinomas to see if it's as effective and safer than standard doses. It includes people getting concurrent chemotherapy or immunotherapy for their condition.
4Treatment groups
Experimental Treatment
Group I: Reduce Dose without Concurrent Chemotherapy Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume.
Group II: Reduce Dose without Concurrent Chemotherapy Non- Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
Group III: Reduce Dose with Concurrent Chemotherapy Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume.
Group IV: Reduce Dose with Concurrent Chemotherapy Non-Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bon SecoursRichmond, VA
Virginia Commonwealth UniversityRichmond, VA
University of VirginiaCharlottesville, VA
Miami Cancer InstituteMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
References
Intensity-modulated radiation therapy in the treatment of head and neck cancer. [2018]Intensity-modulated radiation therapy (IMRT) is a new technical improvement of radiotherapy, in which computer-controlled treatment machines produce multiple beams of radiotherapy whose intensity is optimized to deliver a high dose of radiation to specified volumes, while reducing the dose to adjacent non-target organs. The potential benefits include the ability to deliver higher doses to the target with an improved safety than has previously been possible, and to reduce side effects and complications. Using IMRT to treat some head and neck cancers is especially attractive due to the close vicinity of the targets and many critical, dose-limiting and non-involved structures, and because of the lack of breathing-related motion. The main clinical uncertainties in the use of IMRT for head and neck cancer relate to uncertainties in the extent of radiation to the target areas. In addition, large volumes of adjacent, non-target tissue receive moderate to low radiation doses, raising concerns of increased risk of radiation-related carcinogenesis in young patients. Initial promising clinical data have emerged from IMRT treatment of several head and neck tumor sites.
Systematic review of intraoperative radiation therapy for head and neck cancer. [2023]Multidisciplinary treatments with surgery, radiation therapy, and chemotherapy are the cornerstones in the management of locally advanced head and neck malignancies. In most cases, radiation is delivered via external beam radiation therapy (EBRT). Intraoperative radiation therapy (IORT), on the other hand, is the delivery of precise doses of radiation to selected target volumes within the exposed surgical field while at the operating room. Most studies on its use on head and neck cancers are limited to single-institutional retrospective case series. We performed a systematic review to consolidate the existing literature on IORT for head and neck malignancies. Fifty-two studies representing a mixed population of 2,389 patients were included in this review. IORT via electrons (intraoperative electron radiation therapy), brachytherapy (intraoperative high dose-rate brachytherapy) or photons was administered in numerous settings, but most commonly as part of a reirradiation regimen following salvage surgery for recurrent tumours. Often, additional EBRT was also planned postoperatively. This review illustrates that IORT is a promising treatment modality in head and neck cancer. Multiple single-institutional studies spanning several decades have demonstrated benefit in terms of local control with reasonable toxicity. However, randomised trials comparing it with current standards of care are still needed.
Advances in radiotherapy for head and neck cancer. [2019]Selected advances in radiotherapy for treatment of head and neck cancer are reviewed. These include the role of postoperative radiotherapy, planned postirradiation neck dissection, altered fractionation, neoadjuvant chemotherapy and radiotherapy for laryngeal preservation, three-dimensional conformal treatment planning, charged particle irradiation for skull base tumors, and stereotactic radiosurgery.
Current strategies in radiotherapy of head and neck cancer. [2021]The Intensity Modulated Radiation Therapy (IMRT) together with Image Guided Radiation Therapy (IGRT) improves radiation therapy for head and neck cancer. On the one hand tumors can be better covered with radiation dose and on the other hand normal tissue can be better preserved. Carefully applied this leads to the same tumor control rate with reduced toxicity compared with conventional radiation therapy. Respective to the addition of systemic therapy to irradiation therapy, platinum based radiochemotherapy remains the standard of care and there are first indications, that at least in the primary treatment of head and neck cancer the addition of Cetuximab to a cisplatin-based radiochemotherapy did not improve outcome.
[Intraoperative radiotherapy of ORL cancers. Review of the literature]. [2006]An optimal treatment of head and neck carcinoma is to be targeted at obtaining a good local control of the disease. Intraoperative radiotherapy is one of the means of increasing the irradiation dose in the tumoral volume. It appears particularly suitable for initial treatment of locally advanced head and neck lesions and treatment of recurrence of non irradiated tumors.
Oral complications of head and neck radiotherapy: prevalence and management. [2017]The aim of the study was to evaluate the short-term and long-term toxicity caused by radiation treatment in the head and neck with the technique of intensity-modulated radiotherapy (IMRT).
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Radiation-induced nausea and vomiting in head and neck cancer: Is it something worth considering in the intensity modulated radiotherapy era? "A narrative review". [2021]Radiation therapy is one of the cornerstones in the treatment of head and neck squamous cell carcinomas (HNSCC), alone or in combination with chemotherapy or surgery. Technological advances which occurred over the last few decades have increased the efficacy of radiotherapy (RT), particularly, intensity-modulated RT (IMRT). IMRT can deliver treatments on complex tumoral targets with dose escalation while sparing organs at risk; anyway IMRT deposits dose in unpredictable patterns outside of the target volume with the purpose of improving conformality. Radiation-induced nausea and vomiting (RINV) is a frequent albeit neglected side effect of RT that can lead to delays in treatment with serious consequences on cure rates. According to several guidelines (MASCC 2016, NCCN 2018), RT for HNSCC has traditionally been regarded as a low emetic risk treatment. Nevertheless, several works suggest that IMRT could increase RINV. Further studies are needed to define the exact incidence and the detailed pathophysiology of RINV in patients with HNSCC treated with state of art IMRT techniques, with and without concurrent chemotherapy.
Intensity-modulated radiotherapy for head and neck cancer. [2007]Intensity-modulated radiation therapy (IMRT) is a new radiation delivery technique that allows more precise delivery of radiation and optimization of the dose intensity to specific volumes while sparing the dose to critical normal structures. Using IMRT in head and neck cancers is attractive because of close proximity of the tumor targets to critical normal structures such as the spine, eyes, and parotid glands. IMRT has been shown in a number of clinical sites to improve local control and decrease side effects. Specifically, IMRT has shown the ability to preserve salivary function through sparing of the parotid glands. At the same time, there remain some uncertainties in terms of target delineation, secondary cancers, and side effects to swallowing function that may be increased with IMRT. Multi-institutional studies of IMRT are under way, and these studies, combined with refinements of the technique, should lead to continued improvement in the radiotherapeutic management of head and neck cancer.
Clinical evaluation of intensity-modulated radiotherapy for head and neck cancers. [2022]Radiotherapy and surgery are the principal curative modalities in treatment of head and neck cancer. Conventional two-dimensional and three-dimensional conformal radiotherapy result in significant side effects and altered quality of life. Intensity-modulated radiotherapy (IMRT) can spare the normal tissues, while delivering a curative dose to the tumour-bearing tissues. This article reviews the current role of IMRT in head and neck cancer from the point of view of normal tissue sparing, and also reviews the current published literature by individual head and neck cancer subsites. In addition, we briefly discuss the role of image guidance in head and neck IMRT, and future directions in this area.
Reduction of the dose of radiotherapy to the elective neck in head and neck squamous cell carcinoma; a randomized clinical trial. Effect on late toxicity and tumor control. [2022]A multi-center prospective randomized clinical trial has been performed investigating whether a reduction of the dose to the elective nodal sites in head and neck cancer delivered by intensity modulated radiotherapy (IMRT) would result in a reduction of late side effects without compromising tumor control.