Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT04572100|
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Squamous Cell Carcinoma||Other: Transoral Robotic Surgery (TORS) or Radiotherapy Other: Chemotherapy and Low-Dose Radiotherapy Other: Chemotherapy and High-Dose Radiotherapy Drug: Paclitaxel Drug: Carboplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Induction Chemotherapy Followed by Risk and Response-Stratified Treatment for Locoregional HPV Associated Oropharyngeal Cancer|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||March 1, 2023|
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.
Other: Transoral Robotic Surgery (TORS) or Radiotherapy
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.
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.
Other: Chemotherapy and Low-Dose Radiotherapy
Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
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.
Other: Chemotherapy and High-Dose Radiotherapy
Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
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.
This drug will be combined with carboplatin during induction therapy for 9 weeks.
Other Name: Taxol
This drug will be combined with paclitaxel during induction therapy for 9 weeks.
Other Name: Paraplatin
- 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.
- Changes in Blood Containing HPV-DNA During Response-Based Therapy [ Time Frame: 16 weeks ]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.
- Side Effects of Cisplatin-Based Chemotherapy Treatment [ Time Frame: 16 weeks ]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.
- Tumor Response Among Participants Undergoing Transoral Robotic Surgery [ Time Frame: 20 weeks ]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.
- Time to Disease Recurrence [ Time Frame: 5 years ]Length of time participants remain without evidence of disease.
- Overall Survival [ Time Frame: 5 years ]Length of time until participant death.
- Locoregional Control [ Time Frame: 5 years ]Number of participants who experience local control of their primary tumors after treatment.
- Distant Control [ Time Frame: 5 years ]Number of participants who experience control of metastatic disease (distant tumors) after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572100
|Contact: Ari Rosenberg, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Ari Rosenberg, MD 773-834-3398 email@example.com|
|Principal Investigator:||Ari Rosenberg||University of Chicago|