RECRUITING

Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Conditions

Cancer of the Head and Neck Oropharynx Cancer HPV Positive Oropharyngeal Squamous Cell Carcinoma Throat Carcinoma

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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 trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

Official Title

Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"

Quick Facts

Study Start:2020-09-28

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04444869

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up. * Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment. * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node 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). * Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. * Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16. * Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup: * General history and physical examination within 30 days prior to registration; * Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration; * One of the following combinations of imaging is required within 45 days prior to registration: 1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast); 2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast); 3. or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast); 4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast). * Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial. * Zubrod Performance Status of 0-1 within 30 days prior to registration; * Adequate hematologic function within 14 days prior to registration, defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable. * Adequate renal function within 14 days prior to registration, defined as follows: * Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min * Adequate hepatic function within 14 days prior to registration defined as follows: * Bilirubin \< 2 mg/dl; * AST or ALT \< 3 x the upper limit of normal. * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential	* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive; * Carcinoma of the neck of unknown primary site origin (even if p16 positive); * T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil. * Radiographically matted nodes, that span 6 cm or more; N3 disease * Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle; * Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles; * Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. * Simultaneous primary cancers or separate bilateral primary tumor sites; * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within the last 6 months; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration; * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.

Inclusion Criteria

Exclusion Criteria

* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node 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).
* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
* Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
* Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
* General history and physical examination within 30 days prior to registration;
* Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration;
* One of the following combinations of imaging is required within 45 days prior to registration:
1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);
2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);
3. or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast);
4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
* Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.
* Zubrod Performance Status of 0-1 within 30 days prior to registration;
* Adequate hematologic function within 14 days prior to registration, defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
* Platelets ≥ 100,000 cells/mm3;
* Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.
* Adequate renal function within 14 days prior to registration, defined as follows:
* Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
* Adequate hepatic function within 14 days prior to registration defined as follows:
* Bilirubin \< 2 mg/dl;
* AST or ALT \< 3 x the upper limit of normal.
* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
* Carcinoma of the neck of unknown primary site origin (even if p16 positive);
* T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
* Radiographically matted nodes, that span 6 cm or more; N3 disease
* Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
* Simultaneous primary cancers or separate bilateral primary tumor sites;
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
* Severe, active co-morbidity defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
* Transmural myocardial infarction within the last 6 months;
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.

Contacts and Locations

Study Contact

Gregory Biedermann, MD

CONTACT

(573) 884-8264

biedermanng@health.missouri.edu

Principal Investigator

Gregory Biedermann, MD

PRINCIPAL_INVESTIGATOR

University of Missouri - Ellis Fischel Cancer Center

Study Locations (Sites)

University of Missouri

Columbia, Missouri, 65203

United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Gregory Biedermann, MD, PRINCIPAL_INVESTIGATOR, University of Missouri - Ellis Fischel Cancer Center

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 Date2020-09-28

Study Completion Date2026-06

Study Record Updates

Study Start Date2020-09-28

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Cancer of the Head and Neck
Oropharynx Cancer
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Throat Carcinoma