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Active, not recruitingNCT06167291Updated Oct 7, 2026

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)

A Phase 2 interventional study of Arm 1- Ipsilateral in Oropharyngeal Neoplasms, Robotic Surgery and/or Radiotherapy and Lymphoscintigraphy, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 definitive or PORT radiation. This will be demonstrated by acceptably low contralateral neck failures (\<15%)

Secondary Objectives

To determine:

  1. the relative difference in symptom burden, as measured by the MDASI_HN area-under-the-toxicity curve (AUC), for initial surgical and initial non-surgical therapy cohorts.
  2. Whether omission of the contralateral neck in radiotherapy planning as definitive of PORT treatment for well-lateralized oropharyngeal tumors will impact symptom burden as measured by MDASI AUC, Grade 2 or higher CTCAE v5.0 toxicity, swallow function, and/or feeding tube rates and dependency.
  3. Risk adapted therapy approaches lead to differences in distant-metastasis-free survival (DMFS), ipsilateral neck failure, primary site failure, and whether salvage therapy for contralateral neck failures is feasible and effective compared to historical controls.
02

Conditions studied

  • Oropharyngeal Neoplasms
  • Robotic Surgery and/or Radiotherapy
  • Lymphoscintigraphy
03

In context

Oropharyngeal Neoplasms

373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.

This study's enrollment of 8 is below the median of 48 across 284 interventional studies indexed under Oropharyngeal Neoplasms.

Browse Oropharyngeal Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Arm 1- Ipsilateral

    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

  • RadiationArm 1- Ipsilateral

    Given by I-RT

06

What researchers measure

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

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06167291
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Apr 19, 2024
Primary completion
Dec 9, 2027 (estimated)
Completion
Dec 9, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

David Rosenthal, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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