Status:
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)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Oropharyngeal Neoplasms
Robotic Surgery and/or Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 participa...
Detailed Description
Primary Objectives To determine whether: 1\. Omission of the contralateral neck cancer treatment is safe and toxicity-sparing for participants with well lateralized oropharyngeal HNSCC undergoing de...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed histopathologically-proven p16+ and/or HPV+ HNSCC of the base of tongue or faucial tonsil
- cT1-2N0-1 per AJCC 8th edition staging.
- Tumor does not cross midline, and must be \>1cm from midline
- For tonsil tumors, the primary may extend onto the palate or into the BOT but still be \>1cm from midline
- No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy nor retropharyngeal lymphadenopathy.
- Able to undergo lymphoscintigraphy procedure
- No contraindications for SLNM, adjuvant chemotherapy, RT nor adjuvant/definitive radiotherapy.
- ECOG 0-1
- Age \>18 years
- Ability to understand and the willingness to sign a written informed consent document.
- Exclusion Criteria
- Previous HN Cancer except small skin cancers.
- Any retropharyngeal lymphadenopathy on either MRI, CT, or PET/CT
- Contralateral neck nodal disease radiographically detected per routine diagnostic imaging or SPECT-CT.
- Distant metastatic spread at the time of inclusion
- Chemotherapy or surgery (for the present tumor), prior to inclusion.
- 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
- Recurrent or second primary tumor in the head and neck region
- Non-tongue base or non-faucial tonsil primaries
- Prior history of regionally advanced or distant spread cancers
- Pregnancy or no active contraception for pre-menopausal women
- Known hypersensitivity to iodine or nanocolloid injection
- 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
Exclusion
Key Trial Info
Start Date :
April 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06167291
Start Date
April 19 2024
End Date
December 9 2027
Last Update
August 8 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030