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A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer (DARTBOARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883281
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
David Sher, University of Texas Southwestern Medical Center

Brief Summary:
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. This system is commercially-available and FDA-approved, and UTSW Radiation Oncology has installed two such units. The ability to adjust the dose delivery every day means both that adaptive therapy is possible with every fraction and that the PTV margin can be dramatically reduced/eliminated, since investigators are treating for that day's patient setup. Investigators are therefore proposing a randomized trial using DART with near marginless (ML) setup margins (a 1 mm margin will be retained for intrafractional motion).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy Drug: cisplatin, cetuximab, or carboplatin-paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DARTBOARD: A Prospective Randomized Phase II Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
Actual Study Start Date : February 23, 2022
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Active Comparator: Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy
If a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV.
Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Drug: cisplatin, cetuximab, or carboplatin-paclitaxel
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Experimental: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy
Patients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician.
Radiation: Intensity modulated radiation therapy (IMRT) with or without chemotherapy
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Drug: cisplatin, cetuximab, or carboplatin-paclitaxel
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)




Primary Outcome Measures :
  1. Xerostomia Questionnaire (XQ) [ Time Frame: 1 year ]
    1-year score on the Xerostomia Questionnaire (XQ)


Secondary Outcome Measures :
  1. Patient reported outcome [ Time Frame: 1 year ]
    Patient Reported Outcomes (PRO): European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Score ranges 0-100. Higher the score better the outcome.

  2. Pain and senses score [ Time Frame: 1 year ]
    European Organization for the Research and Treatment of Cancer quality of life questionnaire EORTC HN 35. Score range 0-100. Lower scores are better.

  3. Composite Score [ Time Frame: 1 year ]
    MD Anderson Dysphagia Inventory (MDADI) questionnaire. score ranges 0-100. Higher score is better.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.
  • clinically or radiographically evident measurable disease at the primary site and/or nodal stations
  • diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
  • Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  • Age ≥ 18 years.
  • ECOG Performance Status 0-2
  • All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Negative serum or urine pregnancy test
  • Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Distant metastasis.
  • Inability to undergo PET-CT.
  • Stage I and II glottic carcinoma.
  • Gross total excision of both the primary and nodal disease.
  • Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer
  • Prior invasive malignancy with an expected disease-free interval of less than 3 years.
  • Prior systemic chemotherapy for the study cancer;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  • Subjects may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
  • pregnant or nursing women
  • History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883281


Contacts
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Contact: Kajal Desai 2146458525 Kajal.Desai@UTSouthwestern.edu
Contact: Sarah Neufeld 2146458525 Sarah.Neufeld@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Sher, MD    214-645-8525    david.sher@utsouthwestern.edu   
Contact: Sarah Neufeld       sarah.hardee@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: David Sher, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04883281    
Other Study ID Numbers: STU-2021-0401
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Carboplatin
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological