Oropharyngeal Squamous Cell CarcinomaPhase 1NCT04572100

Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer

A Phase 1 study testing Transoral Robotic Surgery (TORS) or Radiotherapy, Chemotherapy and Low-Dose Radiotherapy and Chemotherapy and High-Dose Radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Oropharyngeal Squamous Cell Carcinoma
What is being tested?: Transoral Robotic Surgery (TORS) or Radiotherapy, Chemotherapy and Low-Dose Radiotherapy and Chemotherapy and High-Dose Radiotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2020to 9 Jan 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago Medical Center
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: 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.

Conditions: Oropharyngeal Squamous Cell Carcinoma
Being tested: Transoral Robotic Surgery (TORS) or Radiotherapy, Chemotherapy and Low-Dose Radiotherapy, Chemotherapy and High-Dose Radiotherapy, Paclitaxel, Carboplatin
Keywords: Oropharyngeal squamous cell carcinoma, head and neck cancer, HPV, human papillomavirus, OPSCC
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transoral Robotic Surgery (TORS) or RadiotherapyOther
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.
Chemotherapy and Low-Dose RadiotherapyOther
Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
Chemotherapy and High-Dose RadiotherapyOther
Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
PaclitaxelDrug
Also called Taxol
This drug will be combined with carboplatin during induction therapy for 9 weeks.
CarboplatinDrug
Also called Paraplatin
This drug will be combined with paclitaxel during induction therapy for 9 weeks.

Study groups in NCT04572100
Study group	Role	What they receive
Group A - Low Risk	Experimental	Participants who have low-risk cancer and significant reduction (greater than 50%) in tumor size following induction therapy will be assigned to this group. Receives: Other: Transoral Robotic Surgery (TORS) or Radiotherapy
Group B - Intermediate Risk	Experimental	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. Receives: Other: Chemotherapy and Low-Dose Radiotherapy
Group C - High-Risk	Experimental	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. Receives: Other: Chemotherapy and High-Dose Radiotherapy
Induction Therapy (Carboplatin and Paclitaxel)	Experimental	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. Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 16 weeks

Secondary outcomes (7)

Changes in Blood Containing HPV-DNA During Response-Based Therapy
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.
Measured: 16 weeks
Side Effects of Cisplatin-Based Chemotherapy Treatment
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.
Measured: 16 weeks
Tumor Response Among Participants Undergoing Transoral Robotic Surgery
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.
Measured: 20 weeks
Time to Disease Recurrence
Length of time participants remain without evidence of disease.
Measured: 5 years
Overall Survival
Length of time until participant death.
Measured: 5 years
Locoregional Control
Number of participants who experience local control of their primary tumors after treatment.
Measured: 5 years
Distant Control
Number of participants who experience control of metastatic disease (distant tumors) after treatment.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20209 Jan 2023

First posted1 Oct 2020
Study start1 Oct 2020
Primary completion9 Jan 2023
Study completion9 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04572100
Sponsor's protocol ID: IRB20-0713
Status last verified: Jul 2023
First submitted: 17 Sep 2020
Last updated: 7 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 34980038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
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RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
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RecruitingObservational study
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All Oropharyngeal Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Induction Chemotherapy Followed by Risk and Response-Stratified Treatment for Locoregional HPV Associated Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT04572100
Acronym / sponsor ID: IRB20-0713
Conditions: Oropharyngeal Squamous Cell Carcinoma
Keywords: Oropharyngeal squamous cell carcinoma, head and neck cancer, HPV, human papillomavirus, OPSCC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 9 Jan 2023 (actual)
Study completion: 9 Jan 2023 (actual)
First posted: 1 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A - Low Risk	Experimental	Other: Transoral Robotic Surgery (TORS) or RadiotherapyParticipants 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	Experimental	Other: Chemotherapy and Low-Dose RadiotherapyParticipants 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	Experimental	Other: Chemotherapy and High-Dose RadiotherapyParticipants 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)	Experimental	Drug: Paclitaxel, Drug: CarboplatinAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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:
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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transoral Robotic Surgery (TORS) or RadiotherapyParticipants 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.	Other	Group A - Low Risk
Chemotherapy and Low-Dose RadiotherapyParticipants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.	Other	Group B - Intermediate Risk
Chemotherapy and High-Dose RadiotherapyParticipants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.	Other	Group C - High-Risk
PaclitaxelAlso: TaxolThis drug will be combined with carboplatin during induction therapy for 9 weeks.	Drug	Induction Therapy (Carboplatin and Paclitaxel)
CarboplatinAlso: ParaplatinThis drug will be combined with paclitaxel during induction therapy for 9 weeks.	Drug	Induction Therapy (Carboplatin and Paclitaxel)

Primary outcome

Feasibility of collection of serial HPV-DNA blood samples in patients undergoing treatment for Oropharyngeal Squamous Cell Carcinoma
Time frame: 16 weeks
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.
Relationship Between HPV-DNA Found in Participant's Blood and Participant Response to Chemotherapy
Time frame: 16 weeks
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.

7 secondary outcomes

Changes in Blood Containing HPV-DNA During Response-Based Therapy
Time frame: 16 weeks
Side Effects of Cisplatin-Based Chemotherapy Treatment
Time frame: 16 weeks
Tumor Response Among Participants Undergoing Transoral Robotic Surgery
Time frame: 20 weeks
Time to Disease Recurrence
Time frame: 5 years
Overall Survival
Time frame: 5 years
Locoregional Control
Time frame: 5 years
Distant Control
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
Derived from this study: PubMed 34980038Rosenberg 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.

Related trials for Oropharyngeal Squamous Cell Carcinoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ari Rosenberg principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of collection of serial HPV-DNA blood samples in patients undergoing treatment for Oropharyngeal Squamous Cell Carcinoma (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.