Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer
Pilot Study of Induction Chemotherapy Followed by Risk and Response-Stratified Treatment for Locoregional HPV Associated Oropharyngeal Cancer
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedJuly 7, 2023
July 1, 2023
2.3 years
September 17, 2020
July 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of collection of serial HPV-DNA blood samples in patients undergoing treatment for Oropharyngeal Squamous Cell Carcinoma
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.
16 weeks
Relationship Between HPV-DNA Found in Participant's Blood and Participant Response to Chemotherapy
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.
16 weeks
Secondary Outcomes (7)
Changes in Blood Containing HPV-DNA During Response-Based Therapy
16 weeks
Side Effects of Cisplatin-Based Chemotherapy Treatment
16 weeks
Tumor Response Among Participants Undergoing Transoral Robotic Surgery
20 weeks
Time to Disease Recurrence
5 years
Overall Survival
5 years
- +2 more secondary outcomes
Study Arms (4)
Group A - Low Risk
EXPERIMENTALParticipants who have low-risk cancer and significant reduction (greater than 50%) in tumor size following induction therapy will be assigned to this group.
Group B - Intermediate Risk
EXPERIMENTALParticipants 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.
Group C - High-Risk
EXPERIMENTALParticipants who have high-risk cancer and less than a 50% reduction in their tumor size following induction therapy will be assigned to this group.
Induction Therapy (Carboplatin and Paclitaxel)
EXPERIMENTALAll 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.
Interventions
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.
Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
This drug will be combined with carboplatin during induction therapy for 9 weeks.
This drug will be combined with paclitaxel during induction therapy for 9 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Related Publications (1)
Rosenberg AJ, Izumchenko E, Pearson A, Gooi Z, Blair E, Karrison T, Juloori A, Ginat D, Cipriani N, Lingen M, Sloane H, Edelstein DL, Keyser K, Fredebohm J, Holtrup F, Jones FS, Haraf D, Agrawal N, Vokes EE. Prospective study evaluating dynamic changes of cell-free HPV DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment. BMC Cancer. 2022 Jan 3;22(1):17. doi: 10.1186/s12885-021-09146-z.
PMID: 34980038DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Rosenberg
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
October 1, 2020
Study Start
October 1, 2020
Primary Completion
January 9, 2023
Study Completion
January 9, 2023
Last Updated
July 7, 2023
Record last verified: 2023-07