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Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT03224000
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Lip Oral Cavity and Pharynx Oropharyngeal Cancer Procedure: Modified Barium Swallow (MBS) Behavioral: Swallowing Questionnaire Behavioral: Symptom Questionnaire Procedure: Video-Strobe Procedure Procedure: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning Procedure: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning Radiation: Intensity Modulated Radiotherapy (IMRT) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: MRI Guided Intensity Modulated Radiotherapy (IMRT)

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Procedure: Modified Barium Swallow (MBS)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Behavioral: Swallowing Questionnaire
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Other Name: The M.D. Anderson Dysphagia Inventory (MDADI)

Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Other Name: The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

Procedure: Video-Strobe Procedure
Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Procedure: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning
IMRT planned with MRI guidance.

Radiation: Intensity Modulated Radiotherapy (IMRT)
Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Other Names:
  • Radiation therapy
  • XRT

Active Comparator: Standard-of-Care Intensity Modulated Radiotherapy (IMRT)

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Procedure: Modified Barium Swallow (MBS)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Behavioral: Swallowing Questionnaire
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Other Name: The M.D. Anderson Dysphagia Inventory (MDADI)

Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Other Name: The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

Procedure: Video-Strobe Procedure
Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Procedure: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning
IMRT planned by standard-of-care.

Radiation: Intensity Modulated Radiotherapy (IMRT)
Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Other Names:
  • Radiation therapy
  • XRT




Primary Outcome Measures :
  1. Locoregional Control [ Time Frame: 6 months post radiation therapy ]
    Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.

  2. Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up [ Time Frame: 6 months post radiation therapy ]

    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

    These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.


  3. Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

  4. Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

  5. Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Modified Barium Swallow Study [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

  6. Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Start of treatment up to 5 years ]
    Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.

  2. Progression-Free Survival [ Time Frame: Start of treatment up to 5 years ]
    Progression-free survival, calculated as time from diagnosis to either death or detection of recurrent disease after an interval without radiographic of clinically evident disease (whichever is earlier), with death or recurrence detection serving as an event and all others censored.

  3. Distant Metastasis-Free Survival [ Time Frame: Start of treatment up to 5 years ]
    Distant metastasis-free survival, calculated as time from diagnosis to either death or detection of disease outside of the head and neck after an interval without radiographic of clinically evident disease (whichever is earlier), with death or metastasis detection serving as an event and all others censored.

  4. Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI) [ Time Frame: Baseline up to 2 years after radiation therapy ]
    Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)

  5. Physician-Reported Toxicity [ Time Frame: Weekly during radiation therapy up to 2 years after radiation therapy ]
    Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.

  6. Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI) [ Time Frame: Baseline up to 2 years after radiation therapy ]
  7. Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  8. Patient Reported Outcome (PRO) Measures of Symptoms Using Xerostomia and Health Questionnaire (EQ-5D-3L) [ Time Frame: Baseline up to 2 years after radiation therapy ]
  9. Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  10. Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline up to 2 years after radiation therapy ]


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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:

  1. Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
  2. Age >/= 18 years
  3. Clinical stage T1-2, N0-1, or small volume N2b (AJCC, 7th ed.), with no distant metastases, based on routine staging workup.
  4. Positive for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
  5. Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
  6. No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
  7. No lymph nodes larger than 3 cm in the greatest dimension
  8. No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
  9. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  10. Dispositioned to single modality photon radiotherapy (i.e. no chemotherapy or previous therapeutic intent surgery).
  11. For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

  1. Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
  2. Pregnant or breast-feeding females
  3. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: *Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
  4. Myocardial infarction within 3 months of registration
  5. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
  6. History of claustrophobia
  7. Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m^2

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): NCT03224000


Contacts
Contact: Clifton Fuller, MD, PHD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Clifton Fuller, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03224000     History of Changes
Other Study ID Numbers: 2015-0851
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of lip oral cavity and pharynx
Oropharyngeal Cancer
Human papilloma virus positive
HPV+
Squamous cell carcinoma of the oropharynx
Squamous cell carcinoma of the tonsil
Squamous cell carcinoma of the base of tongue
Squamous cell carcinoma of the soft palate
Squamous cell carcinoma of the oropharyngeal walls
Magnetic Resonance Imaging Guided Radiotherapy
Standard of Care Radiotherapy Planning
Radiation Therapy
Intensity modulated radiotherapy
IMRT
Modified Barium Swallow
MBS
Swallowing questionnaire
The M.D. Anderson Dysphagia Inventory (MDADI)
Symptom questionnaire
The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
Video-Strobe Procedure

Additional relevant MeSH terms:
Neoplasms
Papilloma
Oropharyngeal Neoplasms
Lip Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Lip Diseases
Mouth Diseases