RECRUITING

Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

Conditions

Oropharyngeal Squamous Cell Carcinoma chemo-radiotherapy cfHPV DNA

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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 study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Official Title

Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate

Quick Facts

Study Start:2022-05-16

Study Completion:2032-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05268614

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 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥ 18 years of age (no upper age limit) 2. T0-3 ≤4cm, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2. 3. Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node. 4. Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable. 5. ECOG Performance Status 0-2 6. ≤10 pack-years of smoking or no smoking for ≥ 10 years 7. Eligible for chemotherapy 8. CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows: * 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.) 9. Adequate renal and hepatic function within 12 weeks prior to treatment, defined as follows: * Serum creatinine \< 2.0 mg/dl * Total bilirubin \< 2 x the institutional ULN (upper limit of normal) * AST or ALT \< 3 x the institutional ULN * Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs. 10. Negative pregnancy test within 3 weeks prior to treatment for women of childbearing potential. 11. People of childbearing potential (POCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 14 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, people of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. * Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or * For people with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL. 12. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 14 months following the last dose of study drug. 13. Patients must provide study specific informed consent prior to study entry.	1. Prior radiotherapy or chemotherapy for this cancer. 2. Prior surgery with curative intent for this OPSCC. 3. Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study. 4. Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam. 5. Prior history of chemotherapy or immunotherapy for cancer within the last 10 years 6. Prior history within 5 years of invasive cancer with the exception of: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin, stage 1-2 * Prostate cancer without distant metastases (stage M0) * Thyroid cancer without distant metastases (stage M0) 7. Prior history of invasive squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone within the last 5 years. 8. Prior history of invasive malignant melanoma or Merkel cell carcinoma of the head or neck treated with surgery alone in the past 5 years. 9. Inhalation smoking of tobacco within the last 10 years with \> 10 pack-year equivalent history. 10. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis. 11. 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 at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol. * Evidence of ACTIVE systemic lupus or scleroderma * Psoriatic arthritis 12. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required. 13. Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 14 months after the last dose of study drug. 14. People who are pregnant or breastfeeding. 15. Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Inclusion Criteria

Exclusion Criteria

1. ≥ 18 years of age (no upper age limit)
2. T0-3 ≤4cm, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.
3. Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
4. Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.
5. ECOG Performance Status 0-2
6. ≤10 pack-years of smoking or no smoking for ≥ 10 years
7. Eligible for chemotherapy
8. CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows:
* 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.)
9. Adequate renal and hepatic function within 12 weeks prior to treatment, defined as follows:
* Serum creatinine \< 2.0 mg/dl
* Total bilirubin \< 2 x the institutional ULN (upper limit of normal)
* AST or ALT \< 3 x the institutional ULN
* Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs.
10. Negative pregnancy test within 3 weeks prior to treatment for women of childbearing potential.
11. People of childbearing potential (POCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 14 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, people of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
* Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
* For people with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
12. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 14 months following the last dose of study drug.
13. Patients must provide study specific informed consent prior to study entry.

1. Prior radiotherapy or chemotherapy for this cancer.
2. Prior surgery with curative intent for this OPSCC.
3. Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.
4. Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam.
5. Prior history of chemotherapy or immunotherapy for cancer within the last 10 years
6. Prior history within 5 years of invasive cancer with the exception of:
* Basal cell carcinoma of the skin
* Squamous cell carcinoma of the skin, stage 1-2
* Prostate cancer without distant metastases (stage M0)
* Thyroid cancer without distant metastases (stage M0)
7. Prior history of invasive squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone within the last 5 years.
8. Prior history of invasive malignant melanoma or Merkel cell carcinoma of the head or neck treated with surgery alone in the past 5 years.
9. Inhalation smoking of tobacco within the last 10 years with \> 10 pack-year equivalent history.
10. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
11. 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 at the time of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
* Evidence of ACTIVE systemic lupus or scleroderma
* Psoriatic arthritis
12. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required.
13. Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 14 months after the last dose of study drug.
14. People who are pregnant or breastfeeding.
15. Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Contacts and Locations

Study Contact

Teresa Ware, MPH

CONTACT

352-273-5739

PMO@cancer.ufl.edu

Principal Investigator

Kathryn Hitchcock, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

UF Health Proton Therapy Institute

Jacksonville, Florida, 32206

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: University of Florida

Kathryn Hitchcock, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2022-05-16

Study Completion Date2032-06

Study Record Updates

Study Start Date2022-05-16

Study Completion Date2032-06

Terms related to this study

Keywords Provided by Researchers

Oropharyngeal Squamous Cell Carcinoma
chemo-radiotherapy
cfHPV DNA

Additional Relevant MeSH Terms

Oropharyngeal Squamous Cell Carcinoma