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Chemotherapy
De-intensified Radiation Therapy + Cisplatin/Nivolumab for Oropharyngeal Cancer
Phase 2 & 3
Waitlist Available
Led By Sue S Yom
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years
Awards & highlights
Study Summary
This trial is studying a lower dose of radiation therapy with nivolumab for patients with HPV-positive oropharyngeal cancer that is early in growth.
Eligible Conditions
- Oropharyngeal Carcinoma
- Squamous Cell Carcinoma
- Oropharyngeal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Distant failure
Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control
Hearing
+5 moreOther outcome measures
Locoregional control for patients with post-RT FDG-PET/CT
PFS for patients with post-RT FDG-PET/CT
Quality of life
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (IMRT, IGRT, nivolumab)Experimental Treatment10 Interventions
Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Group II: Arm II (IMRT, IGRT, cisplatin)Experimental Treatment11 Interventions
Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Group III: Arm I (IMRT, IGRT, cisplatin)Active Control11 Interventions
Patients undergo IMRT or IGRT over 6 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Cisplatin
2013
Completed Phase 3
~1940
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Positron Emission Tomography
2008
Completed Phase 2
~2240
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Nivolumab
2014
Completed Phase 3
~4750
Image Guided Radiation Therapy
2016
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,923,899 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,262 Total Patients Enrolled
Sue S YomPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The exam that is required must be a laryngopharyngoscopy, which can be done with a mirror or in-office direct procedureor regional lymph nodes (for N stage)
Pathologically confirmed diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynxall laboratory values within normal limits
A person's general health and physical examination were normal within the past 56 daysYou have smoked cigarettes in the past, but the total number of cigarette packs you have smoked throughout your life cannot exceed 10 years. The researchers will calculate this based on the number of cigarette packs you smoked per day and how long you smoked for.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (IMRT, IGRT, nivolumab)
- Group 2: Arm I (IMRT, IGRT, cisplatin)
- Group 3: Arm II (IMRT, IGRT, cisplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the conditions that Cisplatin is known to treat?
"Metastatic ureter urothelial carcinoma is most commonly treated with Cisplatin. However, this medication can also be used to mitigate the spread of malignant melanoma of skin, neoplasm metastasis, and other conditions like metastatic hepatocellular carcinoma."
Answered by AI
What other scientific papers have been published that mention Cisplatin?
"As of now, there are 1476 active clinical trials researching Cisplatin. Of these investigations, 370 are in their third phase. Most of these trials take place in Shanghai; however, there are 77586 different locations running Cisplatin clinical trials."
Answered by AI
Where are patients able to enroll in this clinical trial?
"One hundred hospitals are administering this treatment, with a few being located in Torrance, San Francisco and Omaha. It would be ideal to pick the location closest to you to limit travel time if you end up participating."
Answered by AI
How many test subjects are taking part in this experiment?
"In order to successfully run this trial, 711 patients who meet the pre-determined inclusion criteria must enroll. These individuals can come from different locations, such as City of Hope South Bay in Torrance, Nebraska and UCSF Medical Center-Mission Bay in San Francisco, Idaho."
Answered by AI
Are there vacancies in this experiment for new test subjects?
"That is accurate, according to the information displayed on clinicaltrials.gov. The trial was created on 7/10/2019 and updated most recently on 11/16/2022. At this time, 100 different sites are looking for 711 patients total."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Illinois
How old are they?
18 - 65
What site did they apply to?
Northwestern University
CHI Health Good Samaritan
What portion of applicants met pre-screening criteria?
Did not meet criteria
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