Head and Neck CancerPhase 2NCT03096808
Adaptive Radiotherapy for Head and Neck Cancer
A Phase 2 study testing Adaptive Radiotherapy in people with Head and Neck Cancer and Paranasal Sinus Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer
- What is being tested?
- Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Mar 2017to 22 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
- Karnofsky performance status >= 70%
- Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
- Participants must have the ability to understand and the willingness to sign a written consent form
Who cannot join
- Female participants who are pregnant or breast feeding
- Participants who are not able to comply with study and/or follow up procedures
- Participants who have received induction chemotherapy before radiation treatment
- Participants who had prior head and neck radiation therapy
- Participants who are enrolled in a national/international cooperative group trials
- Patients with metastatic disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memoral Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.
- Conditions
- Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer
- Being tested
- Adaptive Radiotherapy
- Keywords
- adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT
- Medical subject headings
- Head and Neck Neoplasms, Paranasal Sinus Neoplasms, Oropharyngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive RadiotherapyRadiation
Also called ART
ART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Radiotherapy | Experimental | Eligible patients will receive IMRT of 60-70Gy in 30-35 once-daily fractions with or without concurrent chemotherapy according to the current standard of care. Receives: Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with locoregional recurrence-free interval
This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start15 Mar 2017
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. Jillian Tsai, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096808
- Sponsor's protocol ID
- 17-148
- Status last verified
- Oct 2021
- First submitted
- 15 Mar 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT03096808
- Acronym / sponsor ID
- 17-148
- Conditions
- Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer
- Keywords
- adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Radiotherapy | Experimental | Radiation: Adaptive RadiotherapyEligible patients will receive IMRT of 60-70Gy in 30-35 once-daily fractions with or without concurrent chemotherapy according to the current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
- Karnofsky performance status >= 70%
- Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
- Participants must have the ability to understand and the willingness to sign a written consent form
Key exclusion criteria (6 listed)
- Female participants who are pregnant or breast feeding
- Participants who are not able to comply with study and/or follow up procedures
- Participants who have received induction chemotherapy before radiation treatment
- Participants who had prior head and neck radiation therapy
- Participants who are enrolled in a national/international cooperative group trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive RadiotherapyAlso: ARTART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss. | Radiation | Adaptive Radiotherapy |
Primary outcome
Number of patients with locoregional recurrence-free interval
Time frame: 2 years
This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Jillian Tsai, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptive Radiotherapy in people with Head and Neck Cancer and Paranasal Sinus Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with locoregional recurrence-free interval (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.