Actively Recruiting
Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
121
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using lower doses of radiation can reduce side effects when combined with standard chemotherapy in people with HPV-positive throat cancer. This Phase 2 study focuses on patients with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma, aiming to improve treatment tolerability while maintaining effectiveness. Chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil (5-FU), paclitaxel, and Abraxane (albumin-bound paclitaxel). Participants are assigned to one of four cohorts based on their specific clinical characteristics. Treatments include radiation over three weeks with a total dose of 30 Gy in 2 Gy fractions, combined with chemotherapy regimens varying by cohort. For example, Cohort B receives carboplatin and paclitaxel starting the same week as radiation; Cohort C includes induction chemotherapy before radiation; and Cohort D focuses on early-stage cases. The study also uses 18F-FMISO PET/CT scans for diagnostic imaging before and during treatment to guide therapy. During the study, participants undergo regular assessments including imaging scans, blood tests to evaluate blood counts and organ function, and clinical evaluations to monitor disease status and side effects. Researchers will measure the number of participants experiencing locoregional cancer recurrence over 2 years. Participants must provide informed consent and comply with study procedures, including MRI scans unless contraindicated. The total participation duration varies depending on treatment and follow-up schedules.
CONDITIONS
Brief Title
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HPV-associated squamous cell carcinoma of the oropharynx confirmed by biopsy or surgical resection
- Measurable disease at primary tumor site or lymph nodes
- No distant metastasis based on FDG PET/CT
- CT or MRI of neck with and without contrast available
- ECOG Performance Status of 0-2 or KPS equal or greater than 50
- Age 18 years or older (patients over 70 may enroll in Cohort B only)
- Adequate blood counts within 30 days prior to registration
- Adequate kidney function within 30 days prior to registration
- Adequate liver function within 30 days prior to registration
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
- Ability to provide informed consent
- Able to undergo MRI scans unless medically contraindicated or approved otherwise
You will not qualify if you...
- Prior radiation therapy to head and neck
- Simultaneous primary cancers outside the oropharynx (exceptions possible with approval)
- Prior invasive cancer unless disease free for 3 years or high cure rate
- Prior systemic chemotherapy for this cancer
- Severe active health conditions such as unstable angina, heart failure, recent heart attack, active infections requiring IV antibiotics, recent severe lung disease requiring hospitalization, or significant liver insufficiency
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive reduced radiation therapy concurrent with chemotherapy. Radiation is given over 3 weeks in 2 Gy fractions totaling 30Gy. Chemotherapy includes 2 cycles of cisplatin or alternative regimens such as carboplatin and 5-fluorouracil depending on tolerance and cohort assignment.
Daily visits during radiation therapy and chemotherapy administration
Duration - 2 years
Participants are monitored for locoregional recurrences and treatment outcomes for up to 2 years after treatment completion.
Periodic visits for monitoring over 2 years
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nancy Lee, MD
H
Heiko Schoder, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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