Trial Title:
Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
NCT ID:
NCT06323460
Condition:
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Oropharyngeal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Cisplatin
Carboplatin
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Given IV
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Blastocarb
Other name:
Carboplat
Other name:
Carboplatin Hexal
Other name:
Carboplatino
Other name:
Carboplatinum
Other name:
Carbosin
Other name:
Carbosol
Other name:
Carbotec
Other name:
CBDCA
Other name:
Displata
Other name:
Ercar
Other name:
JM-8
Other name:
JM8
Other name:
Nealorin
Other name:
Novoplatinum
Other name:
Paraplatin
Other name:
Paraplatin AQ
Other name:
Paraplatine
Other name:
Platinwas
Other name:
Ribocarbo
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given IV
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
External Beam Radiation Therapy
Description:
Undergo external beam radiotherapy
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Definitive Radiation Therapy
Other name:
EBRT
Other name:
External Beam Radiation
Other name:
External Beam Radiotherapy
Other name:
External Beam Radiotherapy (conventional)
Other name:
External Beam RT
Other name:
external radiation
Other name:
External Radiation Therapy
Other name:
external-beam radiation
Other name:
Radiation, External Beam
Other name:
Teleradiotherapy
Other name:
Teletherapy
Other name:
Teletherapy Radiation
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Given IV
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Anzatax
Other name:
Asotax
Other name:
Bristaxol
Other name:
Praxel
Other name:
Taxol
Other name:
Taxol Konzentrat
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (reduced > 95% of TTMV, external beam radiotherapy)
Arm group label:
Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
Summary:
This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA)
to guide lower dose radiation therapy works in treating patients with human
papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses
high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink
tumors. Recently, a blood test has been developed to detect the human papillomavirus in
the blood and determine how many viral particles are present. Researchers want to compare
any good and bad effects of using the lower dose radiation therapy with chemotherapy
compared to the usual standard of care dose chemotherapy in patients who clear the human
papillomavirus particles from their blood.
Detailed description:
PRIMARY OBJECTIVE:
I. To estimate the 3-month post-treatment positron emission tomography (PET) response
rate in patients who have a favorable tumor tissue modified viral (TTMV) tumor profile
(defined as >= 200 copies/mL and reduced to > 95% of this value by week 4).
SECONDARY OBJECTIVES:
I. To assess 2-year progression free survival and toxicity in the reduced dose
chemo-radiation arm.
II. To determine acute and late toxicity as measured by Common Terminology Criteria for
Adverse Events version 5.0 (CTCAE v 5.0).
III. To compare changes in the MD Anderson Dysphagia Inventory (MDADI) of reduced dose
radiation to the current standard of care (69.96 Gy).
IV. To determine whether integration of HPV into the host genome is associated with
circulating TTMV clearance profiles during chemoradiation (CRT).
OUTLINE:
Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients
also receive cisplatin intravenously (IV) weekly or every 3 weeks or
carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks.
Patients undergo blood sample collection for circulating tumor DNA testing at week 4, and
then are assigned to 1 of 2 arms based on the results.
ARM I: Patients with reduced > 95% of TTMV undergo external beam radiotherapy once daily
(QD)5 days a week for 5 weeks. Patients also receive cisplatin IV weekly or every 3 weeks
or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 5 weeks.
Patients undergo PET/computed tomography (CT) scan throughout the trial. Patients also
undergo blood sample collection during screening and throughout the trial.
ARM II: Patients without reduced > 95% of TTMV undergo external beam radiotherapy daily
for 5 days a week for 7 weeks. Patients also receive cisplatin IV weekly or every 3 weeks
or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 7 weeks.
Patients undergo PET/CT scan throughout the trial. Patients also undergo blood sample
collection during screening and throughout the trial.
After completion of study treatment, patients are followed every 3 months for up to 24
months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx
(unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate).
Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of
the primary tumor is not feasible
- P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic
tissue. If staining was done at an outside hospital, central review by the Ohio
State University (OSU) department of pathology must occur prior to trial enrollment
- Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on
Cancer [AJCC] 8th edition) including no evidence of distant metastases based on
general history, imaging, physical examination, and examination with
laryngopharyngoscopy
- Clinical or radiographic evidence of measurable disease at the primary site or lymph
nodes. Simple tonsillectomy or excision of primary without removal of nodal disease
is permitted, as is excision of gross nodes but with intact primary site
- Fludeoxyglucose F-18 (FDG) PET/CT from the base of skull to the mid-thigh is
mandatory and patients cannot be enrolled without a pretreatment PET/CT. PET/CT must
be completed prior to enrollment
- Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma
cell free DNA value of >= 200 copies/mL at baseline
- Patients must provide their smoking history prior to enrollment. Patients must have
=< 10 pack years of smoking. The number of pack years will be calculated using the
following formula: Frequency of smoking (cigarettes/day) x duration of cigarette
smoking (years)/20
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Age >= 18
- Absolute neutrophil count: ≥ 1500/mcL (within 14 days prior to registration)
- Platelets: >= 100,000/mcL (within 14 days prior to registration)
- Hemoglobin >= 8.0 g/dL (use of transfusion or other intervention to achieve this is
acceptable) (within 14 days prior to registration)
- Total bilirubin >= 1.5 x institutional upper limit of normal (within 14 days prior
to registration)
- Aspartate transaminase (AST) or alanine transaminase (ALT) >= 3.0 x institutional
upper limit of normal (within 14 days prior to registration)
- Serum creatinine =< 1.5 x institutional upper limit of normal or creatinine
clearance >= 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to
registration)
- Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible
- Patients with known positive hepatitis B surface antigen indicating acute or chronic
infection would make patient ineligible unless viral load becomes undetectable on
suppressive therapy
- Patients with history of hepatitis C virus must have been treated and cured
- For women of childbearing potential, negative serum or urine pregnancy test within
14 days of registration
- Patient or legally authorized representative must provide study specific informed
consent prior to study entry
Exclusion Criteria:
- Recurrent disease
- Clinical or radiographic evidence of metastatic disease or adenopathy below the
clavicles
- Cancers from an oral cavity site, even if p16 positive
- Patients with simultaneous primary cancers or separate bilateral primary tumors will
be excluded, except for patients with bilateral tonsil cancers
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for
a minimum of 3 years
- Prior systemic chemotherapy or immunotherapy
- Prior radiotherapy that would result in overlap of radiation fields
- Severe active co-morbidity defined as: Unstable angina or congestive heart failure
requiring hospitalization in the last 6 months. Condition requiring systemic
treatment with steroids or immunosuppressive medications within 14 days of
registration
- Patients with active autoimmune disease requiring systemic treatment (disease
modifying agents, corticosteroids, or immunosuppressive drugs
- Patients who are pregnant, nursing, or expected to conceive or father children
- Patients who are allergic to cisplatin, carboplatin, or paclitaxel
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sujith Baliga
Phone:
614-293-5066
Email:
Sujith.baliga@osumc.edu
Investigator:
Last name:
Sujith Baliga
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323460
http://cancer.osu.edu
