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Reduced Radiation + Chemotherapy for Oral Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By Nancy Lee, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate renal function within 30 days prior to registration, defined as follows: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula, CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)], CCr female = 0.85 x (CrCl male)
Subjects must have clinically or radiographically evident measurable disease at nodal stations.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years (+/- 3 months)
Awards & highlights
Study Summary
This trial is comparing a less intense radiation therapy with 2 cycles of standard chemotherapy to the current standard chemoradiation for people with HPV positive and hypoxia negative T1-2, N1-2c oropharyngeal squamous cell carcinoma.
Who is the study for?
Adults with HPV-associated oropharyngeal squamous cell carcinoma, stages T1-2 N1-2c, can join this trial. They must have good blood counts, kidney and liver function, and no history of chemotherapy for the cancer being studied. Pregnant women must test negative. Those with prior head/neck radiation or other cancers (except certain skin cancers) within 3 years are excluded.Check my eligibility
What is being tested?
The study tests if a reduced radiation dose (30 Gy over 3 weeks) combined with standard chemotherapy is as effective as the current treatment for specific throat cancer patients without oxygen-deficient tumors. Cohort B allows optional surgery and proton therapy.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy drugs like Cisplatin or Carboplatin such as nausea, vomiting, kidney damage; Proton Therapy may cause skin redness and sore throat; PET/CT scan has minimal risks but includes exposure to radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, based on recent tests.
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My cancer can be measured or seen on scans in my lymph nodes.
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My cancer is in an early stage and hasn't spread far, confirmed by a special scan.
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I can take care of myself but may not be able to do active work.
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I am 18 years old or older.
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I have HPV-related cancer in my throat area confirmed by a biopsy.
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My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.
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I have HPV-related throat cancer confirmed by a biopsy.
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I have HPV-related cancer in my throat area.
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My kidney function is within the normal range.
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My liver tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years (+/- 3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years (+/- 3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: HPV associated oropharyngeal carcinomaExperimental Treatment6 Interventions
HPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia.
Group II: Arm A: HPV associated oropharyngeal carcinomaExperimental Treatment5 Interventions
HPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia. This arm is closed to accrual.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Therapy
2009
Completed Phase 2
~280
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
5Fluorouracil
2020
Completed Phase 3
~900
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,304 Total Patients Enrolled
1 Trials studying Oropharyngeal Carcinoma
121 Patients Enrolled for Oropharyngeal Carcinoma
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
12 Previous Clinical Trials
1,782 Total Patients Enrolled
1 Trials studying Oropharyngeal Carcinoma
121 Patients Enrolled for Oropharyngeal Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is good, based on recent tests.My cancer can be measured or seen on scans in my lymph nodes.My cancer is in an early stage and hasn't spread far, confirmed by a special scan.I have squamous cell carcinoma in my neck but the primary source is unknown.I can take care of myself but may not be able to do active work.I am 18 years old or older.My kidney function is good as per recent tests.I have HPV-related cancer in my throat area confirmed by a biopsy.I have squamous cell carcinoma in my neck with an unknown primary, but I've had a lymph node biopsy.My hemoglobin level is at least 8.0 g/dl.My kidney function is within the normal range.My kidney function, based on my age, weight, and creatinine levels, is suitable.My liver is functioning well, as confirmed by recent tests.I have squamous cell carcinoma in my neck with an unknown primary, but I've had a lymph node biopsy.My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.I might have other primary cancers, but the lead researcher agrees I can join.I've been cancer-free for 3 years, except for non-dangerous skin cancers.I have not undergone particle therapy like proton therapy for my condition in Cohort A.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I had a major heart attack in the last 6 months.I am currently on IV antibiotics for a bacterial or fungal infection.I haven't been hospitalized for lung problems in the last 30 days.I have liver problems causing jaundice or blood clotting issues.I have HPV-related throat cancer confirmed by a biopsy.I have squamous cell carcinoma in my neck with an unknown primary, but I've had a lymph node biopsy and approval from the study leaders.I have HPV-related cancer in my throat area.My liver tests are within normal limits.I have had a CT or MRI of my neck with and without contrast.I have had radiation therapy for head or neck cancer.I have cancer in areas other than the oropharynx.I have had chemotherapy for this cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: HPV associated oropharyngeal carcinoma
- Group 2: Arm A: HPV associated oropharyngeal carcinoma
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.
Is this investigation still welcoming new participants?
"Affirmative. The data hosted on clinicaltrials.gov reveals that the trial, initially posted in October 2017, is currently accepting prospective participants. A total of 300 candidates are required from 10 distinct medical centres."
Answered by AI
To what extent does this experiment involve patient subjects?
"This medical trial requires 300 compliant patients to participate. These participants can be found in certain locations, such as the Hartford Healthcare (Data Collection) site located in Connecticut or Memorial Sloan Kettering Commack situated in New york state."
Answered by AI
What potential risks are associated with Cisplatin treatments?
"We have moderate confidence in the safety of Cisplatin, as this is a Phase 2 trial with limited data to suggest its efficacy. Our team has thus assigned it a score of 2 on our scale from 1-3."
Answered by AI
Could you please detail any other research conducted on Cisplatin?
"Cisplatin was first investigated at City of Hope Comprehensive Cancer Center in 1997 and since then, 1647 trials have been finalized. A considerable number of active clinical experiments are currently being conducted out of Hartford, Connecticut with 1135 registered studies."
Answered by AI
How many clinical sites have been allocated to carry out this research within North America?
"Clinicialtrials.gov lists 10 sites actively looking for participants in this study, such as Hartford Healthcare (Data Collection) located in Hartfort, Memorial Sloan Kettering Commack and Memoral Sloan Kettering Westchester based in Harrison - with other locations also available."
Answered by AI
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