Testing targeted radiation treatment for oropharyngeal cancer
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)
PHASE2 · M.D. Anderson Cancer Center · NCT06167291
This study tests a new way of giving radiation treatment for oropharyngeal cancer by only targeting the affected side of the neck to see if it is safer and more effective for patients.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06167291 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new approach to radiation therapy for patients with oropharyngeal cancer that is localized to one side of the neck. Instead of treating both sides, which can lead to increased side effects, the study aims to determine if radiation can be safely limited to the affected side. The primary goal is to assess the safety and effectiveness of this targeted approach, while secondary objectives include measuring symptom burden and treatment outcomes. Participants will undergo lymphoscintigraphy to guide treatment planning.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed, localized p16+ and/or HPV+ oropharyngeal cancer that does not cross the midline.
Not a fit: Patients with previous head and neck cancer or evidence of contralateral neck disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce radiation exposure and side effects for patients with localized oropharyngeal cancer.
How similar studies have performed: Other studies have explored targeted radiation approaches, but this specific method is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Previous thyroidectomy or neck dissection (causes aberrant nodal drainage) * 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: David Rosenthal, MD — M.D. Anderson Cancer Center
- Study coordinator: David Rosenthal, MD
- Email: dirosenthal@mdanderson.org
- Phone: (713) 563-2353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oropharyngeal Neoplasms, Robotic Surgery and/or Radiotherapy, Lymphoscintigraphy