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Alkylating agents

Reduced Intensity Chemo for Oropharyngeal Cancer

Phase 2
Recruiting
Led By Kenneth Hu, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx including specific sites
Tissue positive for p16 by immunohistochemical staining
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test if it's possible to give less intense chemo to patients based on how well they respond to treatment halfway through. The goal is to see if this could improve survival rates.

Who is the study for?
This trial is for adults with HPV-positive oropharyngeal cancer confirmed by p16 staining and detectable HPV DNA in the blood. They should have a specific stage of cancer (T1-T2, N1-N2b or T3, N1-N2b), no more than 10 pack-years of smoking history, good performance status, adequate organ function, and no prior allergic reaction to cisplatin. Pregnant women and those with certain health conditions like unstable heart disease or severe infections are excluded.Check my eligibility
What is being tested?
The study tests if lowering the dose of chemoradiation treatment based on how well tumors respond mid-treatment can be effective. It's a phase II trial focusing on patients' progression-free survival over two years using standard radiation combined with Cisplatinum chemotherapy.See study design
What are the potential side effects?
Possible side effects include reactions to Cisplatinum such as nausea, vomiting, kidney damage, hearing loss; and from radiation therapy like skin irritation at the treatment site, fatigue, dry mouth or throat pain due to mucositis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of throat cancer called squamous cell carcinoma.
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My cancer tissue tested positive for p16.
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My cancer is in an early to mid-stage and has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival at 2 years

Trial Design

1Treatment groups
Experimental Treatment
Group I: HPV-Positive Oropharyngeal Carcinoma (OPSCC)Experimental Treatment3 Interventions
Standard radiation therapy + cisplatinum

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,454 Total Patients Enrolled
3 Trials studying Oral Cancers
630 Patients Enrolled for Oral Cancers
Kenneth Hu, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

Cisplatinum (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03215719 — Phase 2
Oral Cancers Research Study Groups: HPV-Positive Oropharyngeal Carcinoma (OPSCC)
Oral Cancers Clinical Trial 2023: Cisplatinum Highlights & Side Effects. Trial Name: NCT03215719 — Phase 2
Cisplatinum (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215719 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide a summary of investigations into Dose-Deescalated Treatment?

"Currently, 689 clinical tests are being undertaken to probe the efficacy of Dose-Deescalated Treatment. Of these studies, 274 have reached Phase 3. These analyses are largely confined to Shanghai; however, there exists a total of 43222 research sites exploring this treatment modality."

Answered by AI

What maladies have been effectively treated using a reduced dosage of medication?

"Dose-Deescalated Treatment is a viable solution for those suffering from advanced ovarian cancer, testicular cancer, and other conditions which are resistant to traditional treatments."

Answered by AI

What is the recruitment size for this clinical experiment?

"Affirmative. Clinicaltrials.gov verifies that this medical study, which was initially published on July 10th 2017, is actively recruiting individuals for participation. Approximately 54 persons must be recruited from a single location."

Answered by AI

Are participants accepted for this experiment currently?

"According to clinicaltrials.gov, the current medical trial is in need of participants. It was first introduced on July 10th 2017 and underwent its most recent update seven days ago on June 6th 2022."

Answered by AI

Are there any safety risks associated with Dose-Deescalated Treatment for those receiving it?

"Our team at Power judged the security of Dose-Deescalated Treatment with a score of 2. This is because, while it has gone through Phase 2 testing, there are no data supporting efficacy and only some information indicative of safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
2017. "Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215719.
~27 spots leftby Dec 2025
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