Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)

NCT04609280 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: HP-00093439
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

This is a phase II, non-randomized, therapeutic trial with the primary objective to determine the efficacy of reduced contralateral (C/L) elective nodal treatment volumes in preventing C/L recurrences at 2 years in patients with p16 positive oropharyngeal squamous cell carcinoma undergoing definitive or adjuvant RT.

Conditions

Head and Neck Cancer; Oropharynx Cancer; Oropharyngeal Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; Oropharynx Cancer; Oropharyngeal Squamous Cell Carcinoma; Radiotherapy; Proton Therapy; Photon Therapy

Outcome Measures

Primary Outcomes (1)

• Elective out-of-field contralateral nodal failure

  Time to failure will be calculated from the date of informed consent until the date of nodal failure in the untreated elective neck sub-volume.

  2-years following completion of radiotherapy

Secondary Outcomes (7)

• Grade 2/3 xerostomia

  2-years following completion of radiotherapy

• Dysphagia using The M.D. Anderson Dysphagia Inventory (MDADI)

  2-years following completion of radiotherapy

• PEG-tube rate

  2-years following completion of radiotherapy

• Overall survival

  2-years following completion of radiotherapy

• Progression-free survival

  2-years following completion of radiotherapy

Study Arms (1)

Reduced C/L elective nodal volume

EXPERIMENTAL

All patients will receive the reduced C/L elective nodal volume as described. Treatment will be delivered via IMRT/VMAT or PBPT.

Radiation: Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT)

Interventions

Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT) RADIATION

Delivered over 6 weeks in 30 daily fractions in the adjuvant setting and over 6.5 weeks in 33 daily fractions in the definitive setting. In the adjuvant setting, areas with positive surgical margins or nodal stations with pathologic extranodal extension will receive 63 Gy. Margin negative resection bed and involved nodal stations without extranodal extension will receive 54 Gy. Low-risk elective nodal volumes (i.e. ceCTV) will receive 51 Gy. In the definitive setting, gross disease will receive 69.96 Gy, areas at high-risk for subclinical disease will receive 60 Gy, and areas at low-risk for harboring subclinical disease (i.e. ceCTV) will receive 52.8 Gy.

Reduced C/L elective nodal volume

Eligibility Criteria

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

You may qualify if:

• Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil or base of tongue)? Note: Cytologic diagnosis from a cervical lymph node (from a paraffin block, not from smears) is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
• Does the patient require elective contralateral radiotherapy in the definitive or adjuvant setting (i.e. base of tongue primary or tonsil with base of tongue invasion, soft palate invasion, or medialized as defined by \> 1/3 of the distance from the tonsil to the midline of the soft palate?
• Does the patient have clinical stage T1-4, N0, N1 or N3, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT)?
• Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?
• Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?
• Is the patient ≥ 18 years of age?
• For women of childbearing potential, was a serum pregnancy test completed within 2 weeks of initiation or radiotherapy?
• If yes, was the serum pregnancy test negative?
• If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.
• Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?

You may not qualify if:

• Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?
• Does the patient have a carcinoma of the neck of unknown primary origin?
• Does the patient have distant metastasis?
• Does the patient have prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years?
• Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?
• Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?
• Did the patient have prior surgery of the head and neck excluding superficial removal of cutaneous skin malignancies?
• Is the patient homeless?
• Does the patient have an active drug or alcohol dependency?
• Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?
• Radiographic evidence of contralateral nodal disease as described below. 1) Max standardized uptake value (SUV) greater than 3.0, or 2) Short-axis diameter is \> 1.5 cm for level II nodes, \> 0.8 cm for retropharyngeal node, or \> 1.0 cm for level III, IV, or V, or 3) Central necrosis or heterogeneous enhancement

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (6)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

UMMC

Baltimore, Maryland, 21201, United States

Location

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Upper Chesapeake Health

Bel Air, Maryland, 21014, United States

Location

Central Maryland Radiation Oncology

Columbia, Maryland, 21044, United States

Location

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Matthew Witek, MD

  University of Maryland/Maryland Proton Treatment 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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: March 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)