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)

NCT06167291 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2022-0915NCI-2023-10400
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Oropharyngeal Neoplasms; Robotic Surgery and/or Radiotherapy; Lymphoscintigraphy

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Arm 1- Ipsilateral

EXPERIMENTAL

Participants with ipsilateral-only drainage (Arm 1- Ipsilateral) will be randomized to assign definitive ipsilateral RT (without concurrent chemotherapy) -vs- ipsilateral surgery (TORS/ND).

Radiation: Arm 1- Ipsilateral

Interventions

Arm 1- Ipsilateral RADIATION

Given by I-RT

Arm 1- Ipsilateral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• David Rosenthal, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: April 19, 2024
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)