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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540899
• Other study ID #: ACR 3518
• Status: Recruiting
• Phase: Phase 1
• Start date: November 8, 2023
• Est. completion date: November 2028

Study information

• Verified date: November 2023
• Source: American College of Radiology
• Contact: Etta Pisano, MD
• Phone: 215-574-3150
• Email: episano[@]acr.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma Not Otherwise Specified (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 II, III or 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 18-75

• Negative pregnancy test within 14 days prior to registration for women of childbearing potential

• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.

• 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.

• Feeding tube (gastric or jejuno) 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Larynx
• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Oropharynx

Intervention

Radiation:
• Hypofractionated Postoperative Radiotherapy
Hypofractionated Postoperative Radiation Therapy

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology	RTOG Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity (DLT)	All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable.; Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summarized using proportions for binary outcomes and the exact binomial method.	From the start of H-PORT up 12 months post-radiation
Secondary	Incidence of Adverse Events	Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Counts and percentages will be provided for the worst grade AE experienced.	From the start of H-PORT up to 12 months post-radiation
Secondary	Rate of radiation interruptions	Counts and percentages will be provided for treatment interruptions.	From the start to the end of H-PORT, assessed up to 4 weeks
Secondary	Rate of radiation discontinuations	Counts and percentages will be provided for treatment discontinuations.	From the start to the end of H-PORT, assessed up to 4 weeks