Adaptive Radiotherapy for Head and Neck Cancer

NCT03096808 — Phase 2, Completed, 64 participants, Memorial Sloan Kettering Cancer Center

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A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy

RegistryNCT03096808
StatusCompleted
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment64 (Actual)
SponsorMemorial Sloan Kettering Cancer Center (Other)
ConditionsHead and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer, Hypopharynx Cancer
InterventionsAdaptive Radiotherapy (Radiation)
Datesstart 2017-03-15, primary completion 2021-10-22, completion 2021-10-22, first posted 2017-03-30, last updated 2021-10-26
Locations8 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Head and Neck Cancer All trials for Paranasal Sinus Cancer All trials of Adaptive Radiotherapy

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Adaptive RadiotherapyExperimentalRadiation: 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.
  • Adaptive Radiotherapy (Radiation), also known as 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.

+Outcome measures

Primary outcomes

  • Number of patients with locoregional recurrence-free interval [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (8)

FacilityCityCountryStatus
Memorial Sloan Kettering Basking RidgeBasking Ridge, New JerseyUnited States
Memorial Sloan Kettering MonmouthMiddletown, New JerseyUnited States
Memorial Sloan Kettering BergenMontvale, New JerseyUnited States
Memorial Sloan Kettering CommackCommack, New YorkUnited States
Memoral Sloan Kettering WestchesterHarrison, New YorkUnited States
Memorial Sloan Kettering Cancer CenterNew York, New YorkUnited States
Memorial Sloan Kettering Rockville CentreRockville Centre, New YorkUnited States
Memorial Sloan Kettering NassauUniondale, New YorkUnited States

+Investigators