RECRUITING

Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

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Conditions

Oropharyngeal NeoplasmsRobotic Surgery and/or RadiotherapyLymphoscintigraphy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.

Official Title

Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

Quick Facts

Study Start:2024-04-19
Study Completion:2027-12-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06167291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed histopathologically-proven p16+ and/or HPV+ HNSCC of the base of tongue or faucial tonsil
  2. * cT1-2N0-1 per AJCC 8th edition staging.
  3. * Tumor does not cross midline, and must be \>1cm from midline
  4. * For tonsil tumors, the primary may extend onto the palate or into the BOT but still be \>1cm from midline
  5. * No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy nor retropharyngeal lymphadenopathy.
  6. * Able to undergo lymphoscintigraphy procedure
  7. * No contraindications for SLNM, adjuvant chemotherapy, RT nor adjuvant/definitive radiotherapy.
  8. * ECOG 0-1
  9. * Age \>18 years
  10. * Ability to understand and the willingness to sign a written informed consent document.
  11. * Previous HN Cancer except small skin cancers.
  12. * Any retropharyngeal lymphadenopathy on either MRI, CT, or PET/CT
  13. * Contralateral neck nodal disease radiographically detected per routine diagnostic imaging or SPECT-CT.
  14. * Distant metastatic spread at the time of inclusion
  15. * Chemotherapy or surgery (for the present tumor), prior to inclusion.
  16. * Previous radiation treatment in the head and neck region, for any reason, except for cutaneous lesions that would not lead to overlap with definitive bilateral neck irradiation
  17. * Previous thyroidectomy or neck dissection (causes aberrant nodal drainage)
  18. * Recurrent or second primary tumor in the head and neck region
  19. * Non-tongue base or non-faucial tonsil primaries
  20. * Prior history of regionally advanced or distant spread cancers
  21. * Pregnancy or no active contraception for pre-menopausal women
  22. * Known hypersensitivity to iodine or nanocolloid injection
  23. * Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

David Rosenthal, MD
CONTACT
(713) 563-2353
dirosenthal@mdanderson.org

Principal Investigator

David Rosenthal, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • David Rosenthal, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19
Study Completion Date2027-12-09

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2027-12-09

Terms related to this study

Additional Relevant MeSH Terms

  • Oropharyngeal Neoplasms
  • Robotic Surgery and/or Radiotherapy
  • Lymphoscintigraphy