Testing a shorter radiation treatment for patients after surgery for head and neck cancer

Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer

This study is testing a shorter radiation treatment for people with intermediate-risk head and neck cancer after surgery to see if it is safe and works well.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: American College of Radiology (other)
• Drugs / interventions: cetuximab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT05540899 on ClinicalTrials.gov

What this trial studies

This phase I trial aims to evaluate the safety and feasibility of hypofractionated postoperative radiotherapy (H-PORT) for patients with intermediate-risk head and neck cancer who have undergone surgery. The study will administer a total of 50 Gy of radiation over 4 weeks, with careful monitoring for treatment-related adverse events and patient compliance. Participants will be followed up at various intervals post-treatment to assess outcomes and tolerability. The goal is to determine if this approach can be further evaluated in a phase II clinical trial.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed intermediate-risk squamous cell carcinoma of the oral cavity, oropharynx, or larynx who have undergone complete surgical resection.

Not a fit: Patients with hypopharyngeal cancer or those with distant metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective postoperative radiation option for patients with intermediate-risk head and neck cancer.

How similar studies have performed: Other studies have explored hypofractionated radiation therapy, showing promising results, but this specific approach is still being evaluated for safety.

Eligibility criteria

Inclusion Criteria:

* Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
* Clinical stage I-IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.

  * General history and physical examination prior to registration;
  * Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.
* Total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer).
* One or more indications for postoperative radiotherapy, based upon pathologic findings:

  * Perineural invasion;
  * Lymphovascular invasion;
  * Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular Extension);
  * Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin);
  * Pathologically confirmed T3 or T4a primary tumor;
  * T2 oral cavity cancer with ≥ 5 mm depth of invasion.
* Zubrod Performance Status 0-1.
* Age 18-80.
* Negative pregnancy test within 14 days prior to registration for participants who may become pregnant.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

Exclusion Criteria:

* Recurrence of the study cancer.
* History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
* Pregnancy and individuals unwilling to discontinue nursing.
* Reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration
* Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.
* Per the operative and/or pathology report, positive margin(s) \[defined as tumor present at the cut or inked edge of the tumor\], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.

Where this trial is running

Hershey, Pennsylvania

• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Etta Pisano, MD — American College of Radiology
• Study coordinator: Etta Pisano, MD

Conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Oral Cavity