ACTIVE_NOT_RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-08

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05540899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Etta Pisano, MD

PRINCIPAL_INVESTIGATOR

American College of Radiology

Study Locations (Sites)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Collaborators and Investigators

Sponsor: American College of Radiology

Etta Pisano, MD, PRINCIPAL_INVESTIGATOR, American College of Radiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2028-11

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

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