Clinical trial NCT05540899: Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer
Official title: Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Lead sponsor: American College of Radiology
Sponsor class: OTHER
Collaborators: name: RTOG Foundation, Inc.
First posted: 2022-09-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.

SECONDARY OBJECTIVES:

I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion.

II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.

ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer.

Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy.

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.

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: From the start of H-PORT up 12 months post-radiation
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: From the start of H-PORT up to 12 months post-radiation
measure: Rate of radiation interruptions
timeFrame: From the start to the end of H-PORT, assessed up to 4 weeks
measure: Rate of radiation discontinuations
timeFrame: From the start to the end of H-PORT, assessed up to 4 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: American College of Radiology
name: Etta Pisano, MD
role: PRINCIPAL_INVESTIGATOR
References: