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Unilateral Neck Radiotherapy in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03622164
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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Brief Summary:

Patients with head and neck cancer typically undergo a surgical procedure to remove the lymph nodes that could contain disease on both sides of the neck. After surgery, radiotherapy is given (with or without chemotherapy) to the area that underwent surgery and both sides of the neck, even if disease was only found on one side. Giving radiotherapy to both sides of the neck commonly results in high rates of side effects, which in turn affects patient quality of life.

There is growing evidence from some other studies that support the safety of omitting radiotherapy after surgery in the side of the neck with no disease. With this study, the investigators are hoping to justify its routine use and, if successful, the standard of care could be to receive radiation on only one side of the neck instead of both sides. This could alleviate the extent of some side effects and improve patient quality of life.

Participants will be randomized into one of the following groups to receive radiotherapy as follows:

Arm 1 (Non-experimental intervention): standard intervention: Radiotherapy to both sides of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.

Arm 2 (Experimental intervention): Radiotherapy to one side of the neck. Treatment will begin a maximum of 8 weeks from the surgery date.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck) Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Non-experimental intervention
Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck).
 Radiation: Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)
CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease
Experimental: Experimental intervention
Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck).
 Radiation: Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)
CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.


Outcome Measures
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Primary Outcome Measures :
  1. Locoregional control [ Time Frame: At 24 months ]
    Locoregional failure is defined as disease recurrence (by imaging, clinical exam, or biopsy) in the neck or at the primary site.


Secondary Outcome Measures :
  1. Overall survival and disease-specific survival [ Time Frame: 5 years after diagnosis or the start of treatment. ]
    Percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.

  2. University of Washington Quality of Life Questionnaire - Radiation Therapy Oncology Group (UW-QOL - RTOG) modification [ Time Frame: At 6, 12, 18 and 24 months post radiotherapy ]

    The University of Washington Quality of Life questionnaire Radiation Therapy Oncology Group (RTOG) modification, is a health related quality of life tool for use in head and neck cancer patients receiving RT.

    The UW-QOL RTOG modification consists of 15 items with response options ranging from 10 to 50, in multiples of 10. That is, the lowest symptom burden is rated as 10, whereas the highest symptom burden is rated as 50. The individual item scores are totaled and then averaged to obtain the final score. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower HRQOL.


  3. Xerostomia [ Time Frame: At 6, 12, 18 and 24 months post radiotherapy ]
    Overall score

  4. Acute toxicity [ Time Frame: Weekly throughout RT treatment (approximately 6 weeks) ]
    Toxicity scoring will be carried out to include salivary gland, mucositis, skin, and fatigue grading according the CTCAE version 4.0 scoring criteria.


Eligibility Criteria
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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:

Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria:

  • Age ≥18
  • Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx.
  • Squamous cell carcinoma confirmed by histology.
  • Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with >= 10 lymph nodes removed from the contralateral neck
  • The contralateral neck is pathologically negative
  • Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes.
  • Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

  • Previous radiation to the head and neck area
  • Pregnancy
  • Other contraindications to radiation treatment (e.g. severe connective tissue disease).
Contacts and Locations
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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): NCT03622164


Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Rufus Scrimger, MD    780-432-8517    rufus.scrimger@ahs.ca   
Principal Investigator: Rufus Scrimger, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT03622164     History of Changes
Other Study ID Numbers: IIT-0002
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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

Keywords provided by AHS Cancer Control Alberta:
radiotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms