- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572100
Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer
July 6, 2023 updated by: University of Chicago
Pilot Study of Induction Chemotherapy Followed by Risk and Response-Stratified Treatment for Locoregional HPV Associated Oropharyngeal Cancer
Doctors leading this study will give blood tests to head and neck cancer participants during the beginning of chemotherapy treatment (also known as induction therapy) to see if these blood tests can help predict tumor shrinkage after therapy and reduce the amount of additional radiotherapy or chemotherapy treatment the participant may need.
This study will also examine ways to reduce overall side effects of treatment using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects must have clinically confirmed Human papillomavirus(HPV)-positive head and neck squamous cell cancer of the back of the mouth/throat (oropharynx). Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
HPV testing must be compliant with the following criteria:
- P16INK4a immunohistochemistry (p16 IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).
- p16 IHC positivity is to be validated using an HPV Polymerase chain reaction (PCR - a type of DNA copying method).
- HPV PCR must demonstrate HPV16 or HPV18 subtype
- Availability of greater than 10 unstained 5 micron slides (to be provided to HTRC at the University of Chicago). Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
- Participants must be at least 18 years old.
- Participants with American Joint Committee on Cancer (AJCC) (8th edition, 2018) N1 (>=3cm), N2-N3 nodal disease or T3-T4 primary tumor.
- Measurable disease (either primary site or nodal disease) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- No previous radiation or chemotherapy for a head and neck cancer.
- No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
- Eastern Cooperate Oncology Group performance status 0-1
- Normal organ function clinically confirmed by medical records.
- Participants must sign a study-specific informed consent form prior to study entry. Participants should have the ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
- Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).
Exclusion Criteria:
- Any sign of metastatic disease (M1 disease).
- Non-HPV16/18 subtype
- Unidentifiable primary site of cancer.
- Other medical illnesses that may impair the participant's ability to receive therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility)
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
- Patients receiving other investigational agents.
- Prior systemic anti-cancer treatment within the last 8 weeks.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has a history of HIV.
- Has known active Hepatitis B or hepatitis C. If eradicated, patient is eligible.
- Has received a live vaccine within 28 days of planned start of study therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group A - Low Risk
Participants who have low-risk cancer and significant reduction (greater than 50%) in tumor size following induction therapy will be assigned to this group.
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Participants assigned to this group will receive transoral robotic surgery (TORs) or radiotherapy.
Radiotherapy is given once a day for 5 weeks.
A percentage of subjects who undergo surgery may need further radiotherapy with or without chemotherapy based on the results of the surgery.
TORs is surgery in which a robot with arms is used to remove cancer from hard-to-reach areas of the mouth and throat.
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Experimental: Group B - Intermediate Risk
Participants who have low-risk cancer and intermediate reduction (30-50%) in tumor size or high-risk cancer with significant reduction (greater than or equal to 50%) in tumor size following induction therapy will be assigned to this group.
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Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
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Experimental: Group C - High-Risk
Participants who have high-risk cancer and less than a 50% reduction in their tumor size following induction therapy will be assigned to this group.
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Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
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Experimental: Induction Therapy (Carboplatin and Paclitaxel)
All study participants will be assigned to this group to first receive induction therapy using a combination of carboplatin and paclitaxel.
Participant response to this phase of therapy will determine which group (low-risk, intermediate risk or high-risk) the participant will be in.
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This drug will be combined with carboplatin during induction therapy for 9 weeks.
Other Names:
This drug will be combined with paclitaxel during induction therapy for 9 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of collection of serial HPV-DNA blood samples in patients undergoing treatment for Oropharyngeal Squamous Cell Carcinoma
Time Frame: 16 weeks
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To determine if it is possible (feasibility) to measure HPV-DNA using blood tests among participants undergoing induction chemotherapy followed by a second round of response-based therapy for their HPV-associated cancer.
This feasibility will be determined by measuring the proportion of patients who complete chemotherapy treatment and HPV-DNA assessments.
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16 weeks
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Relationship Between HPV-DNA Found in Participant's Blood and Participant Response to Chemotherapy
Time Frame: 16 weeks
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To evaluate the relationship (aka correlation) between the amount of HPV-DNA found in a participant's plasma/blood and the participant's response to induction chemotherapy based on how their tumor responds to treatment.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Blood Containing HPV-DNA During Response-Based Therapy
Time Frame: 16 weeks
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To evaluate changes in blood containing HPV-DNA during a second round of chemotherapy (known as response-based chemo-radiotherapy) that will be based on how the participant responded to their first/induction phase of chemotherapy treatment.
This outcome will be measured by checking quantitative HPV DNA in plasma with each cycle of induction chemotherapy, weekly during radiation treatment, and following completion of radiation at set time points within the study.
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16 weeks
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Side Effects of Cisplatin-Based Chemotherapy Treatment
Time Frame: 16 weeks
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To evaluate the side effects of weekly cisplatin-based treatment in participants receiving chemotherapy followed by a second round of response-based therapy for their HPV-associated cancer.
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16 weeks
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Tumor Response Among Participants Undergoing Transoral Robotic Surgery
Time Frame: 20 weeks
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To determine how participant's tumor/cancer responds when they are undergoing Transoral Robotic Surgery (TORS) following induction chemotherapy.
TORs is surgery in which a robot with arms is used to remove cancer from hard-to-reach areas of the mouth and throat.
Data about how patients' tumors respond in this study will be compared to similar data from a previous study.
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20 weeks
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Time to Disease Recurrence
Time Frame: 5 years
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Length of time participants remain without evidence of disease.
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5 years
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Overall Survival
Time Frame: 5 years
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Length of time until participant death.
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5 years
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Locoregional Control
Time Frame: 5 years
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Number of participants who experience local control of their primary tumors after treatment.
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5 years
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Distant Control
Time Frame: 5 years
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Number of participants who experience control of metastatic disease (distant tumors) after treatment.
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ari Rosenberg, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
January 9, 2023
Study Completion (Actual)
January 9, 2023
Study Registration Dates
First Submitted
September 17, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 1, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- IRB20-0713
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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